FDA Orange Book
Generic for Carbaglu
Carbaglu contains carglumic acid. 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 Carbaglu is carglumic acid. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Carbaglu products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, for suspension, oral | 200MG | Marketed (Rx) | AB | 2 | AB |
NDA 022562, held by RECORDATI RARE DISEASES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic carglumic acid
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVITIUM PHARMA LLC | 213729 | AB (A-rated, therapeutically equivalent) | October 13, 2021 | 200MG |
| NAVINTA LLC | 213395 | AB (A-rated, therapeutically equivalent) | June 22, 2022 | 200MG |
Carbaglu exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-345 | Orphan drug exclusivity | January 22, 2028 | 022562 |
Carbaglu NDC codes
Questions
Is there a generic for Carbaglu?
Yes. The generic name for Carbaglu is carglumic acid. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Carbaglu?
The active ingredient in Carbaglu is carglumic acid, 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.