FDA Orange Book
Generic for Nitrolingual Pumpspray
Nitrolingual Pumpspray 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 Nitrolingual Pumpspray is nitroglycerin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Nitrolingual Pumpspray products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, sublingual | 0.4MG/SPRAY | Marketed (Rx) | AB | 2 | AB |
NDA 018705, held by POHL BOSKAMP. 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 |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 091496 | AB (A-rated, therapeutically equivalent) | September 20, 2013 | 0.4MG/SPRAY |
| EPIC PHARMA LLC | 204681 | AB (A-rated, therapeutically equivalent) | August 21, 2026 | 0.4MG/SPRAY |
Nitrolingual Pumpspray patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7872049 | March 12, 2029 | Drug product | U-2223 | 018705 |
Nitrolingual Pumpspray NDC codes
Questions
Is there a generic for Nitrolingual Pumpspray?
Yes. The generic name for Nitrolingual Pumpspray is nitroglycerin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Nitrolingual Pumpspray?
The active ingredient in Nitrolingual Pumpspray is nitroglycerin, per the FDA Orange Book.
When does the Nitrolingual Pumpspray patent expire?
The last patent listed for Nitrolingual Pumpspray in the Orange Book expires March 12, 2029. A listed patent expiry date is not a generic launch date.
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.