FDA Orange Book
Generic for Pronestyl
Pronestyl contains procainamide. 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 Pronestyl is procainamide. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 8 Pronestyl products the Orange Book lists.
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Pronestyl products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 250MG | Discontinued | None | 0 | None |
| capsule, oral | 375MG | Discontinued | None | 0 | None |
| capsule, oral | 500MG | Discontinued | None | 0 | None |
| injectable, injection | 100MG/ML | Discontinued | None | 5 | AP |
| injectable, injection | 500MG/ML | Discontinued | None | 3 | AP |
| tablet, oral | 250MG | Discontinued | None | 0 | None |
| tablet, oral | 375MG | Discontinued | None | 0 | None |
| tablet, oral | 500MG | Discontinued | None | 0 | None |
NDA 007335, 017371, held by APOTHECON INC DIV BRISTOL MYERS SQUIBB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic procainamide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| INTERNATIONAL MEDICATION SYSTEM | 088636 | AP (A-rated, therapeutically equivalent) | July 31, 1984 | 100MG/ML |
| HOSPIRA INC | 089069 | AP (A-rated, therapeutically equivalent) | February 12, 1986 | 100MG/ML |
| NEXUS PHARMACEUTICALS LLC | 206332 | AP (A-rated, therapeutically equivalent) | October 13, 2017 | 100MG/ML, 500MG/ML |
| GLAND PHARMA LTD | 218135 | AP (A-rated, therapeutically equivalent) | July 22, 2024 | 100MG/ML, 500MG/ML |
| CAPLIN STERILES LTD | 218674 | AP (A-rated, therapeutically equivalent) | February 4, 2025 | 100MG/ML, 500MG/ML |
Questions
Is there a generic for Pronestyl?
Yes. The generic name for Pronestyl is procainamide. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 8 Pronestyl products the Orange Book lists.
What is the generic name for Pronestyl?
The active ingredient in Pronestyl is procainamide, 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.