FDA Orange Book
Generic for Endari
Endari contains l-glutamine. 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 Endari is l-glutamine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Endari products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, oral | 5GM/PACKET | Marketed (Rx) | AA | 3 | AA |
NDA 208587, held by EMMAUS MEDICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic l-glutamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVITIUM PHARMA LLC | 215647 | AA (A-rated, therapeutically equivalent) | July 8, 2024 | 5GM/PACKET |
| PHARMOBEDIENT CONSULTING LLC | 219750 | AA (A-rated, therapeutically equivalent) | May 14, 2026 | 5GM/PACKET |
| ANNORA PHARMA PRIVATE LTD | 219722 | AA (A-rated, therapeutically equivalent) | May 26, 2026 | 5GM/PACKET |
Endari NDC codes
Questions
Is there a generic for Endari?
Yes. The generic name for Endari is l-glutamine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Endari?
The active ingredient in Endari is l-glutamine, 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.