FDA Orange Book
Generic for Pamine
Pamine contains methscopolamine bromide. 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 Pamine is methscopolamine bromide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Pamine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 2.5MG | Discontinued | None | 3 | AA |
NDA 008848, held by FOUGERA PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methscopolamine bromide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BRECKENRIDGE PHARMACEUTICAL INC | 040642 | AA (A-rated, therapeutically equivalent) | December 6, 2011 | 2.5MG |
| UNICHEM LABORATORIES LTD | 200602 | AA (A-rated, therapeutically equivalent) | September 24, 2012 | 2.5MG |
| NE RX PHARMA LLC | 216786 | AA (A-rated, therapeutically equivalent) | February 1, 2024 | 2.5MG |
Questions
Is there a generic for Pamine?
Yes. The generic name for Pamine is methscopolamine bromide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Pamine?
The active ingredient in Pamine is methscopolamine bromide, 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.