Is there a generic for Oxacillin sodium?

Yes. The FDA Orange Book lists 27 approved generic (ANDA) applications for Oxacillin sodium, referencing the brand BACTOCILL IN PLASTIC CONTAINER. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Oxacillin sodium?

BACTOCILL IN PLASTIC CONTAINER (NDA 050640, BAXTER HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Oxacillin sodium are approved?

Oxacillin sodium is approved in the following dosage forms: capsule, for solution, injectable, powder.

FDA Orange Book · active-ingredient family

Oxacillin sodium

Oxacillin sodium: 4 brands, 27 generics; first approved Mar 26, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 27 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

BACTOCILL IN PLASTIC CONTAINERRLDRS

BAXTER HLTHCARENDA 05064019892 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE/ML	INJECTABLE	INJECTION	Rx	—
EQ 40MG BASE/ML	INJECTABLE	INJECTION	Rx	—

OXACILLIN SODIUMRLD

APOTHECONNDA 050195—5 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 4GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

PROSTAPHLIN

APOTHECONNDA 050118—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

PROSTAPHLIN

APOTHECONNDA 050194—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/5ML	FOR SOLUTION	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (27)

OXACILLIN SODIUM

FRESENIUS KABI USAANDA 2061992020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

OXACILLIN SODIUMRS

FRESENIUS KABI USAANDA 20619820202 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

OXACILLIN SODIUM

WOCKHARDT BIO AGANDA 2071482017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

OXACILLIN SODIUM

PIRAMAL CRITICALANDA 2067602017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

OXACILLIN SODIUM

PIRAMAL CRITICALANDA 20668120172 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

OXACILLIN SODIUM

WOCKHARDT BIO AGANDA 20714720172 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

OXACILLIN SODIUM

HOSPIRAANDA 20395020152 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

OXACILLIN SODIUM

ONESOURCE SPECIALTYANDA 09148620142 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

OXACILLIN SODIUM

EUGIA PHARMA SPECLTSANDA 20153920132 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

OXACILLIN SODIUM

EUGIA PHARMA SPECLTSANDA 2015382013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

OXACILLIN SODIUM

SAGENT PHARMSANDA 09124620122 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

OXACILLIN SODIUMRS

SAGENT PHARMSANDA 0912452012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

OXACILLIN SODIUM

ISTITUTO BIO ITA SPAANDA 06279819955 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 125MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 250MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

OXACILLIN SODIUM

ELKINS SINNANDA 06271119896 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 4GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

OXACILLIN SODIUM

WATSON LABS INCANDA 06285619885 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 4GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

OXACILLIN SODIUM

WATSON LABS INCANDA 0629841988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

OXACILLIN SODIUM

SANDOZANDA 06273719862 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	POWDER	INTRAVENOUS	Discontinued	—
EQ 2GM BASE/VIAL	POWDER	INTRAVENOUS	Discontinued	—

BACTOCILL

GLAXOSMITHKLINEANDA 06273619862 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

BACTOCILL

GLAXOSMITHKLINEANDA 06133419825 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 4GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

BACTOCILL

GLAXOSMITHKLINEANDA 061336—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

BACTOCILL

GLAXOSMITHKLINEANDA 062241—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

OXACILLIN SODIUM

ANI PHARMSANDA 062222—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

OXACILLIN SODIUM

APOTHECONANDA 061450—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—

BACTOCILL

GLAXOSMITHKLINEANDA 062321—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/5ML	FOR SOLUTION	ORAL	Discontinued	—

OXACILLIN SODIUM

APOTHECONANDA 061457—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/5ML	FOR SOLUTION	ORAL	Discontinued	—

OXACILLIN SODIUM

TEVAANDA 062252—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/5ML	FOR SOLUTION	ORAL	Discontinued	—

OXACILLIN SODIUM

SANDOZANDA 061490—5 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	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

Mar 26, 1982

44 yr 11 mo ago

Most recent approval

Jul 27, 2020

6 yr 1 mo ago

Approvals span 1982–2020 across 31 FDA applications.

Brand (NDA) 413%

Generic (ANDA) 2787%

Oxacillin sodium — 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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