FDA Orange Book
Generic for Transderm-nitro
Transderm-nitro contains nitroglycerin. 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 Transderm-nitro is nitroglycerin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB2. Generics match 4 of the 5 Transderm-nitro products the Orange Book lists.
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Transderm-nitro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| film, extended release, transdermal | 0.1MG/HR | Discontinued | None | 2 | AB2 |
| film, extended release, transdermal | 0.2MG/HR | Discontinued | None | 2 | AB2 |
| film, extended release, transdermal | 0.4MG/HR | Discontinued | None | 2 | AB2 |
| film, extended release, transdermal | 0.6MG/HR | Discontinued | None | 2 | AB2 |
| film, extended release, transdermal | 0.8MG/HR | Discontinued | None | 0 | None |
NDA 020144, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nitroglycerin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN TECHNOLOGIES INC | 074559 | AB2 (A-rated, therapeutically equivalent) | February 6, 1998 | 0.1MG/HR, 0.2MG/HR, 0.4MG/HR, 0.6MG/HR |
| ZYDUS PHARMACEUTICALS USA INC | 089884 | AB2 (A-rated, therapeutically equivalent) | October 30, 1998 | 0.2MG/HR |
| ZYDUS PHARMACEUTICALS USA INC | 089886 | AB2 (A-rated, therapeutically equivalent) | October 30, 1998 | 0.6MG/HR |
| ZYDUS PHARMACEUTICALS USA INC | 089885 | AB2 (A-rated, therapeutically equivalent) | October 30, 2017 | 0.1MG/HR, 0.4MG/HR |
Questions
Is there a generic for Transderm-nitro?
Yes. The generic name for Transderm-nitro is nitroglycerin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB2. Generics match 4 of the 5 Transderm-nitro products the Orange Book lists.
What is the generic name for Transderm-nitro?
The active ingredient in Transderm-nitro is nitroglycerin, 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.