FDA Orange Book

Generic for Opticrom

Opticrom contains cromolyn. 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 Opticrom is cromolyn. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.

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Opticrom products in the Orange Book

Opticrom products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution/drops, ophthalmic4%DiscontinuedNone1None

NDA 018155, held by ALLERGAN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic cromolyn

Approved generic versions of Opticrom
CompanyANDATE codeApprovedStrengths
SANDOZ INC075282None (No TE code listed)June 16, 19994%

Questions

Is there a generic for Opticrom?

Yes. The generic name for Opticrom is cromolyn. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.

What is the generic name for Opticrom?

The active ingredient in Opticrom is cromolyn, 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.

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