Is there a generic for Methicillin sodium?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Methicillin sodium, referencing the brand STAPHCILLIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Methicillin sodium?

STAPHCILLIN (NDA 050117, APOTHECON) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Methicillin sodium are approved?

Methicillin sodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Methicillin sodium

Methicillin sodium is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:STAPHCILLIN · NDA 050117

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
STAPHCILLIN×3	APOTHECON	NDA 050117	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
STAPHCILLIN×3	APOTHECON	ANDA 061449	—	Approved Prior to Jan 1, 1982

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.

Methicillin sodium — frequently asked questions

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

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