Is there a generic for Dicloxacillin sodium?

Yes. The FDA Orange Book lists 6 approved generic (ANDA) applications for Dicloxacillin sodium, referencing the brand PATHOCIL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dicloxacillin sodium?

PATHOCIL (NDA 050011, WYETH AYERST) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Dicloxacillin sodium are approved?

Dicloxacillin sodium is approved in the following dosage forms: capsule, for suspension.

FDA Orange Book · active-ingredient family

Dicloxacillin sodium

Dicloxacillin sodium: 3 brands, 6 generics; first approved Jun 03, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 6 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

PATHOCILRLD

WYETH AYERSTNDA 050011—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE	ORAL	Discontinued	—
EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE	ORAL	Discontinued	—

DYNAPEN

APOTHECONNDA 050337—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 62.5MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

PATHOCIL

WYETH AYERSTNDA 050092—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 62.5MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (6)

DICLOXACILLIN SODIUM

AUROBINDO PHARMAANDA 21684520222 strengths

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

DICLOXACILLIN SODIUM

TEVAANDA 06228619822 strengths

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

DICLOXACILLIN SODIUM

CHARTWELL RXANDA 061454—3 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 125MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

DYCILL

GLAXOSMITHKLINEANDA 060254—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	—

DYCILL

GLAXOSMITHKLINEANDA 062238—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	—

DICLOXACILLIN SODIUM

APOTHECONANDA 061455—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 62.5MG BASE/5ML	FOR SUSPENSION	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

Jun 03, 1982

44 yr 9 mo ago

Most recent approval

Sep 23, 2022

3 yr 10 mo ago

Approvals span 1982–2022 across 9 FDA applications.

Brand (NDA) 333%

Generic (ANDA) 667%

Dicloxacillin 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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