FDA Orange Book
Generic for Nitro-dur
Nitro-dur 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 Nitro-dur 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 6 Nitro-dur products the Orange Book lists.
Run it in Rivvi
Map Nitro-dur and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Nitro-dur 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 | Marketed (Rx) | None | 2 | AB2 |
| film, extended release, transdermal | 0.2MG/HR | Marketed (Rx) | None | 2 | AB2 |
| film, extended release, transdermal | 0.3MG/HR | Marketed (Rx) | None | 0 | None |
| film, extended release, transdermal | 0.4MG/HR | Marketed (Rx) | None | 2 | AB2 |
| film, extended release, transdermal | 0.6MG/HR | Marketed (Rx) | None | 2 | AB2 |
| film, extended release, transdermal | 0.8MG/HR | Marketed (Rx) | None | 0 | None |
NDA 020145, held by USPHARMA LTD. 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 |
Nitro-dur NDC codes
Questions
Is there a generic for Nitro-dur?
Yes. The generic name for Nitro-dur 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 6 Nitro-dur products the Orange Book lists.
What is the generic name for Nitro-dur?
The active ingredient in Nitro-dur 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.
More on Nitro-dur and Nitroglycerin
- What is Nitroglycerin used for?FDA label uses
- Is Nitroglycerin a controlled substance?Federal schedule
- Generic for NitromistFDA Orange Book
- Generic for Transderm-nitroFDA Orange Book
- Generic for Nitro IVFDA Orange Book
- Generic for Nitro-bidFDA Orange Book
- Generic for NitrostatFDA Orange Book
- Generic for TridilFDA Orange Book
- Generic for RectivFDA Orange Book
- Generic for Nitrolingual PumpsprayFDA Orange Book
- Nitrate Vasodilators listFDA drug class
- NDC 50742-513Nitro-dur NDC record
- NDC 50742-514Nitro-dur NDC record
- NDC 50742-515Nitro-dur NDC record