FDA Orange Book

Generic for Acular

Acular contains ketorolac. 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 Acular is ketorolac. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.

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Acular products in the Orange Book

Acular products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
solution/drops, ophthalmic	0.5%	Marketed (Rx)	AT	4	AT

NDA 019700, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic ketorolac

Approved generic versions of Acular
Company	ANDA	TE code	Approved	Strengths
APOTEX INC	076109	AT (A-rated, therapeutically equivalent)	November 5, 2009	0.5%
SANDOZ INC	076583	AT (A-rated, therapeutically equivalent)	November 5, 2009	0.5%
MICRO LABS LTD INDIA	203410	AT (A-rated, therapeutically equivalent)	April 5, 2019	0.5%
CAPLIN STERILES LTD	218204	AT (A-rated, therapeutically equivalent)	March 26, 2024	0.5%

Acular NDC codes

0023-2181

Questions

Is there a generic for Acular?

Yes. The generic name for Acular is ketorolac. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.

What is the generic name for Acular?

The active ingredient in Acular is ketorolac, 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.