Is there a generic for Acetaminophen; codeine phosphate?

Yes. The FDA Orange Book lists 108 approved generic (ANDA) applications for Acetaminophen; codeine phosphate. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What dosage forms of Acetaminophen; codeine phosphate are approved?

Acetaminophen; codeine phosphate is approved in the following dosage forms: capsule, solution, suspension, tablet.

FDA Orange Book · active-ingredient family

Acetaminophen; codeine phosphate

Acetaminophen; codeine phosphate: 0 brands, 108 generics; first approved Apr 13, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 108 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

108

Listed patents

Presentations

131

Abbreviated applications

Generic (ANDA) products (108)

ACETAMINOPHEN AND CODEINE PHOSPHATE

ELITE LABS INCANDA 21241820193 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Rx	AA
300MG;30MG	TABLET	ORAL	Rx	AA
300MG;60MG	TABLET	ORAL	Rx	AA

ACETAMINOPHEN AND CODEINE PHOSPHATE

HIBROW HLTHCAREANDA 21161020193 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Rx	AA
300MG;30MG	TABLET	ORAL	Rx	AA
300MG;60MG	TABLET	ORAL	Rx	AA

ACETAMINOPHEN AND CODEINE PHOSPHATE

AUROLIFE PHARMA LLCANDA 20280020133 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Rx	AA
300MG;30MG	TABLET	ORAL	Rx	AA
300MG;60MG	TABLET	ORAL	Rx	AA

ACETAMINOPHEN AND CODEINE PHOSPHATE

CHARTWELL MOLECULARANDA 0912382011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG/5ML;12MG/5ML	SOLUTION	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

AMNEAL PHARMS NYANDA 0407792008

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Rx	AA

CODRIX

WATSON LABS FLORIDAANDA 0404882003

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG;60MG	TABLET	ORAL	Discontinued	—

CODRIX

WATSON LABS FLORIDAANDA 0404412003

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG;30MG	TABLET	ORAL	Discontinued	—

CODRIX

WATSON LABS FLORIDAANDA 0404472003

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG;15MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

WATSON LABS FLORIDAANDA 04044320033 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Discontinued	—
300MG;30MG	TABLET	ORAL	Discontinued	—
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

ABLEANDA 0404522002

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

ABLEANDA 0404592002

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATERS

SPECGX LLCANDA 04041920013 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Rx	AA
300MG;30MG	TABLET	ORAL	Rx	AA
300MG;60MG	TABLET	ORAL	Rx	AA

ACETAMINOPHEN AND CODEINE PHOSPHATE

DURAMED PHARMS BARRANDA 04022319973 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Discontinued	—
300MG;30MG	TABLET	ORAL	Discontinued	—
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

DAVA PHARMS INCANDA 0400981996

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG/5ML;12MG/5ML	SOLUTION	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

PAI HOLDINGSANDA 0401191996

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG/5ML;12MG/5ML	SOLUTION	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

CHARTWELLANDA 0899971994

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

CHARTWELLANDA 0899981994

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

CHARTWELLANDA 0899991994

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

CHARTWELLANDA 0894501992

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG/5ML;12MG/5ML	SOLUTION	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

FOSUN PHARMAANDA 0812501992

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

FOSUN PHARMAANDA 0812491992

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

MIKARTANDA 0893631991

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
650MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

ROXANEANDA 0895111989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG;15MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

ROXANEANDA 0895121989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

ROXANEANDA 0895131989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

STRIDES PHARMA INTLANDA 0899901988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Rx	AA

ACETAMINOPHEN AND CODEINE PHOSPHATE

STRIDES PHARMA INTLANDA 0898051988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Rx	AA

ACETAMINOPHEN AND CODEINE PHOSPHATE

STRIDES PHARMA INTLANDA 0898281988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Rx	AA

ACETAMINOPHEN AND CODEINE PHOSPHATE

RHODES PHARMSANDA 08967319883 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—
300MG;15MG	TABLET	ORAL	Discontinued	—
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

AM THERAPANDA 0894781987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

AM THERAPANDA 0894811987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

AM THERAPANDA 0894791987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

AM THERAPANDA 0894821987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

AM THERAPANDA 0894801987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

AM THERAPANDA 0894831987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

PUREPAC PHARMANDA 0890801986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

SUPERPHARMANDA 0892531986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

SUPERPHARMANDA 0892541986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

MIKARTANDA 0892311986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
650MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

MIKARTANDA 0892381986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

MIKARTANDA 0892441986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

SUPERPHARMANDA 0891831985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

SUPERPHARMANDA 0891841985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

SUPERPHARMANDA 0891851985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATERLD

ANI PHARMSANDA 08862919853 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—
300MG;15MG	TABLET	ORAL	Discontinued	—
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

TEVAANDA 0885371984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	CAPSULE	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

TEVAANDA 0885991984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	CAPSULE	ORAL	Discontinued	—

PAPA-DEINE #3

VANGARDANDA 0880371984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

PAPA-DEINE #4

VANGARDANDA 0887151984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

DURAMED PHARMS BARRANDA 0883531984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

DURAMED PHARMS BARRANDA 0883541984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

DURAMED PHARMS BARRANDA 0883551984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

TEVAANDA 0883241983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	CAPSULE	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

PURACAP PHARMANDA 0877621982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

USL PHARMAANDA 0879191982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

USL PHARMAANDA 0879201982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

WATSON LABSANDA 0872771982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

WATSON LABSANDA 0872761982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

WATSON LABSANDA 0872751982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

MUTUAL PHARMANDA 0876531982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

PHENAPHEN W/ CODEINE NO. 2

ROBINS AHANDA 084444—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;15MG	CAPSULE	ORAL	Discontinued	—

PHENAPHEN W/ CODEINE NO. 3RLD

ROBINS AHANDA 084445—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;30MG	CAPSULE	ORAL	Discontinued	—

PHENAPHEN W/ CODEINE NO. 4RLD

ROBINS AHANDA 084446—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;60MG	CAPSULE	ORAL	Discontinued	—

PROVAL #3

SOLVAYANDA 085685—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;30MG	CAPSULE	ORAL	Discontinued	—

TYLENOL W/ CODEINE NO. 3

ORTHO MCNEIL PHARMANDA 087422—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	CAPSULE	ORAL	Discontinued	—

TYLENOL W/ CODEINE NO. 4

ORTHO MCNEIL PHARMANDA 087421—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	CAPSULE	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATERLD

ACTAVIS MID ATLANTICANDA 085861—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG/5ML;12MG/5ML	SOLUTION	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATERS

GENUS LIFESCIENCESANDA 087508—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG/5ML;12MG/5ML	SOLUTION	ORAL	Rx	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

PHARMOBEDIENTANDA 087006—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG/5ML;12MG/5ML	SOLUTION	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

STRIDES PHARMAANDA 086366—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG/5ML;12MG/5ML	SOLUTION	ORAL	Discontinued	—

TYLENOL W/ CODEINERLD

ORTHO MCNEIL PHARMANDA 085057—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG/5ML;12MG/5ML	SOLUTION	ORAL	Discontinued	—

CAPITAL AND CODEINE

ACTAVIS MID ATLANTICANDA 085883—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG/5ML;12MG/5ML	SUSPENSION	ORAL	Discontinued	—

CAPITAL AND CODEINE

VALEANT PHARMS LLCANDA 086024—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG/5ML;12MG/5ML	SUSPENSION	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

EVERYLIFEANDA 085217—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

HALSEYANDA 083871—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

HALSEYANDA 083872—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

HALSEYANDA 086549—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

KV PHARMANDA 085288—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

KV PHARMANDA 085365—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

KV PHARMANDA 085364—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;15MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

KV PHARMANDA 085363—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;45MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

LEDERLEANDA 087141—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

MUTUAL PHARMANDA 085795—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

MUTUAL PHARMANDA 085794—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATERLD

PUREPAC PHARMANDA 086681—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

PUREPAC PHARMANDA 086683—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

ROXANEANDA 084659—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

ROXANEANDA 084656—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

ROXANEANDA 084667—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATERLD

SANDOZANDA 087433—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

SANDOZANDA 085291—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATERLD

SANDOZANDA 085917—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

SANDOZANDA 085964—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

SANDOZANDA 087423—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

SUN PHARM INDS LTDANDA 085868—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

SUN PHARM INDS LTDANDA 087083—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Rx	AA

ACETAMINOPHEN AND CODEINE PHOSPHATE

VALEANT PHARM INTLANDA 085896—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

VITARINEANDA 085676—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

WARNER CHILCOTTANDA 085992—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;15MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

WARNER CHILCOTTANDA 085218—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

WARNER CHILCOTTANDA 087306—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

WHITEWORTH TOWN PLSNANDA 084360—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND CODEINE PHOSPHATE

WHITEWORTH TOWN PLSNANDA 085607—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;60MG	TABLET	ORAL	Discontinued	—

CAPITAL AND CODEINE

CARNRICKANDA 083643—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;30MG	TABLET	ORAL	Discontinued	—

EMPRACET W/ CODEINE PHOSPHATE #3

GLAXOSMITHKLINEANDA 083951—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;30MG	TABLET	ORAL	Discontinued	—
300MG;60MG	TABLET	ORAL	Discontinued	—

PHENAPHEN-650 W/ CODEINE

ROBINS AHANDA 085856—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
650MG;30MG	TABLET	ORAL	Discontinued	—

TYLENOL W/ CODEINE

ORTHO MCNEIL PHARMANDA 085056—4 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
325MG;15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
325MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
325MG;60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

TYLENOL W/ CODEINE NO. 2RLD

JANSSEN PHARMSANDA 085055—4 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG;7.5MG	TABLET	ORAL	Discontinued	—
300MG;15MG	TABLET	ORAL	Discontinued	—
300MG;30MG	TABLET	ORAL	Discontinued	—
300MG;60MG	TABLET	ORAL	Discontinued	—

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Apr 13, 1982

44 yr 11 mo ago

Most recent approval

Sep 10, 2019

6 yr 11 mo ago

Approvals span 1982–2019 across 108 FDA applications.

Brand (NDA) 00%

Generic (ANDA) 108100%

Acetaminophen; codeine phosphate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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