FDA Orange Book
Generic for Nitro IV
Nitro IV 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 IV is nitroglycerin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
Run it in Rivvi
Map Nitro IV 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 IV products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 5MG/ML | Discontinued | None | 1 | None |
NDA 018672, held by G POHL BOSKAMP GMBH AND 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 |
Questions
Is there a generic for Nitro IV?
Yes. The generic name for Nitro IV is nitroglycerin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Nitro IV?
The active ingredient in Nitro IV 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.