FDA Orange Book
Generic for Proglycem
Proglycem contains diazoxide. 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 Proglycem is diazoxide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 3 Proglycem products the Orange Book lists.
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Proglycem 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 |
| capsule, oral | 50MG | Discontinued | None | 0 | None |
| suspension, oral | 50MG/ML | Marketed (Rx) | AB | 2 | AB |
NDA 017425, 017453, held by TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic diazoxide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| E5 PHARMA INC | 211050 | AB (A-rated, therapeutically equivalent) | December 20, 2019 | 50MG/ML |
| NOVITIUM PHARMA LLC | 210799 | AB (A-rated, therapeutically equivalent) | July 8, 2020 | 50MG/ML |
Proglycem NDC codes
Questions
Is there a generic for Proglycem?
Yes. The generic name for Proglycem is diazoxide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 3 Proglycem products the Orange Book lists.
What is the generic name for Proglycem?
The active ingredient in Proglycem is diazoxide, 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.