Is there a generic for Acetaminophen; propoxyphene hydrochloride?

Yes. The FDA Orange Book lists 7 approved generic (ANDA) applications for Acetaminophen; propoxyphene hydrochloride, referencing the brand DARVOCET. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Acetaminophen; propoxyphene hydrochloride?

DARVOCET (NDA 016844, AAIPHARMA LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Acetaminophen; propoxyphene hydrochloride are approved?

Acetaminophen; propoxyphene hydrochloride is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Acetaminophen; propoxyphene hydrochloride

Acetaminophen; propoxyphene hydrochloride: 1 brand, 7 generics; first approved Jul 18, 1989; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 7 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

DARVOCET

AAIPHARMA LLCNDA 016844—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;32.5MG	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (7)

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN

VINTAGE PHARMSANDA 0405072003

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
650MG;65MG	TABLET	ORAL	Discontinued	—

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN

WATSON LABSANDA 0401391996

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
650MG;65MG	TABLET	ORAL	Discontinued	—

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN

SANDOZANDA 0899591989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
650MG;65MG	TABLET	ORAL	Discontinued	—

DOLENE AP-65

LEDERLEANDA 085100—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
650MG;65MG	TABLET	ORAL	Discontinued	—

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN

MYLANANDA 083689—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;32MG	TABLET	ORAL	Discontinued	—

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN

MYLANANDA 083978—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
650MG;65MG	TABLET	ORAL	Discontinued	—

WYGESIC

CARACOANDA 084999—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
650MG;65MG	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

Jul 18, 1989

37 yr 6 mo ago

Most recent approval

Jul 30, 2003

23 yr 3 mo ago

Approvals span 1989–2003 across 8 FDA applications.

Brand (NDA) 113%

Generic (ANDA) 788%

Acetaminophen; propoxyphene hydrochloride — 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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