FDA Orange Book
Generic for Cuvposa
Cuvposa contains glycopyrrolate. 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 Cuvposa is glycopyrrolate. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Cuvposa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 1MG/5ML | Marketed (Rx) | AA | 11 | AA |
NDA 022571, held by MERZ PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic glycopyrrolate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 204438 | AA (A-rated, therapeutically equivalent) | August 9, 2021 | 1MG/5ML |
| ANNORA PHARMA PRIVATE LTD | 213698 | AA (A-rated, therapeutically equivalent) | July 5, 2022 | 1MG/5ML |
| COHANCE LIFESCIENCES LTD | 212467 | AA (A-rated, therapeutically equivalent) | July 5, 2022 | 1MG/5ML |
| GRANULES PHARMACEUTICALS INC | 214735 | AA (A-rated, therapeutically equivalent) | August 19, 2024 | 1MG/5ML |
| CHARTWELL RX SCIENCES LLC | 216368 | AA (A-rated, therapeutically equivalent) | August 28, 2024 | 1MG/5ML |
| SCIEGEN PHARMACEUTICALS INC | 216297 | AA (A-rated, therapeutically equivalent) | October 7, 2024 | 1MG/5ML |
| AUROBINDO PHARMA LTD | 214847 | AA (A-rated, therapeutically equivalent) | December 31, 2024 | 1MG/5ML |
| MSN LABORATORIES PRIVATE LTD | 216084 | AA (A-rated, therapeutically equivalent) | April 8, 2025 | 1MG/5ML |
| AJENAT PHARMACEUTICALS LLC | 219267 | AA (A-rated, therapeutically equivalent) | October 27, 2025 | 1MG/5ML |
| BIONPHARMA INC | 220062 | AA (A-rated, therapeutically equivalent) | December 23, 2025 | 1MG/5ML |
| QUAGEN PHARMACEUTICALS LLC | 216910 | AA (A-rated, therapeutically equivalent) | May 18, 2026 | 1MG/5ML |
Cuvposa NDC codes
Questions
Is there a generic for Cuvposa?
Yes. The generic name for Cuvposa is glycopyrrolate. 11 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 Cuvposa?
The active ingredient in Cuvposa is glycopyrrolate, 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 Cuvposa and Glycopyrrolate
- What is Glycopyrrolate used for?FDA label uses
- Is Glycopyrrolate a controlled substance?Federal schedule
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- Generic for Glyrx-pfFDA Orange Book
- Generic for Robinul ForteFDA Orange Book
- Anticholinergics listFDA drug class
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- NDC 0259-0501Cuvposa NDC record