FDA Orange Book
Generic for Quinaglute
Quinaglute contains quinidine gluconate. 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 Quinaglute is quinidine gluconate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Quinaglute products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 324MG | Discontinued | None | 2 | AB |
NDA 016647, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic quinidine gluconate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES INC | 089338 | AB (A-rated, therapeutically equivalent) | February 11, 1987 | 324MG |
| ADAPTIS PHARMA PRIVATE LTD | 212589 | AB (A-rated, therapeutically equivalent) | September 17, 2021 | 324MG |
Questions
Is there a generic for Quinaglute?
Yes. The generic name for Quinaglute is quinidine gluconate. 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 Quinaglute?
The active ingredient in Quinaglute is quinidine gluconate, 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.