FDA Orange Book
Generic for Nitrostat
Nitrostat 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 Nitrostat is nitroglycerin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Nitrostat products the Orange Book lists.
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Nitrostat products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 0.8MG/ML | Discontinued | None | 0 | None |
| injectable, injection | 5MG/ML | Discontinued | None | 1 | None |
| tablet, sublingual | 0.3MG | Marketed (Rx) | AB | 7 | AB |
| tablet, sublingual | 0.4MG | Marketed (Rx) | AB | 7 | AB |
| tablet, sublingual | 0.6MG | Marketed (Rx) | AB | 7 | AB |
NDA 018588, 021134, held by PARKE DAVIS DIV WARNER LAMBERT CO. 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 |
|---|---|---|---|---|
| AMERICAN REGENT INC | 072034 | None (No TE code listed) | May 24, 1988 | 5MG/ML |
| DR REDDYS LABORATORIES INC | 208191 | AB (A-rated, therapeutically equivalent) | August 26, 2016 | 0.3MG, 0.4MG, 0.6MG |
| GLENMARK SPECIALTY SA | 206391 | AB (A-rated, therapeutically equivalent) | September 19, 2017 | 0.3MG, 0.4MG, 0.6MG |
| NATCO PHARMA LTD | 211604 | AB (A-rated, therapeutically equivalent) | April 30, 2019 | 0.3MG, 0.4MG, 0.6MG |
| RUBICON RESEARCH LTD | 209779 | AB (A-rated, therapeutically equivalent) | May 3, 2021 | 0.3MG, 0.4MG, 0.6MG |
| AUROBINDO PHARMA LTD | 217879 | AB (A-rated, therapeutically equivalent) | October 26, 2023 | 0.3MG, 0.4MG, 0.6MG |
| MANKIND PHARMA LTD | 217970 | AB (A-rated, therapeutically equivalent) | December 5, 2023 | 0.3MG, 0.4MG, 0.6MG |
| PHARMOBEDIENT CONSULTING LLC | 218583 | AB (A-rated, therapeutically equivalent) | October 15, 2024 | 0.3MG, 0.4MG, 0.6MG |
Nitrostat NDC codes
Questions
Is there a generic for Nitrostat?
Yes. The generic name for Nitrostat is nitroglycerin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Nitrostat products the Orange Book lists.
What is the generic name for Nitrostat?
The active ingredient in Nitrostat 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.
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