FDA Orange Book
Generic for Gastrocrom
Gastrocrom 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 Gastrocrom is cromolyn. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 1 of the 2 Gastrocrom products the Orange Book lists.
Run it in Rivvi
Map Gastrocrom and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Gastrocrom products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Discontinued | None | 0 | None |
| concentrate, oral | 100MG/5ML | Marketed (Rx) | AA | 3 | AA |
NDA 019188, 020479, held by UCB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cromolyn
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDINGS INC | 202583 | AA (A-rated, therapeutically equivalent) | October 27, 2011 | 100MG/5ML |
| MICRO LABS LTD INDIA | 202745 | AA (A-rated, therapeutically equivalent) | April 4, 2013 | 100MG/5ML |
| AILEX PHARMACEUTICALS LLC | 209264 | AA (A-rated, therapeutically equivalent) | October 16, 2017 | 100MG/5ML |
Gastrocrom NDC codes
Questions
Is there a generic for Gastrocrom?
Yes. The generic name for Gastrocrom is cromolyn. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 1 of the 2 Gastrocrom products the Orange Book lists.
What is the generic name for Gastrocrom?
The active ingredient in Gastrocrom 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.