FDA Orange Book

Generic for Marcaine

Marcaine contains bupivacaine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Marcaine is bupivacaine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

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Marcaine products in the Orange Book

Marcaine products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
injectable, spinal	0.75%	Marketed (Rx)	AP	3	AP

NDA 018692, held by HOSPIRA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic bupivacaine

Approved generic versions of Marcaine
Company	ANDA	TE code	Approved	Strengths
HOSPIRA INC	071810	AP (A-rated, therapeutically equivalent)	December 11, 1987	0.75%
B BRAUN MEDICAL INC	209087	AP (A-rated, therapeutically equivalent)	April 2, 2019	0.75%
HUONS CO LTD	212822	AP (A-rated, therapeutically equivalent)	December 30, 2019	0.75%

Marcaine NDC codes

0409-1761

Questions

Is there a generic for Marcaine?

Yes. The generic name for Marcaine is bupivacaine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

What is the generic name for Marcaine?

The active ingredient in Marcaine is bupivacaine, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.