FDA Orange Book
Is there a generic for Glyrx-pf?
Glyrx-pf 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Glyrx-pf (glycopyrrolate).
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Glyrx-pf products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intramuscular, intravenous | 0.2MG/ML (0.2MG/ML) | Discontinued | None | 0 | None |
| solution, intramuscular, intravenous | 0.4MG/2ML (0.2MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intramuscular, intravenous | 0.6MG/3ML (0.2MG/ML) | Discontinued | None | 0 | None |
| solution, intramuscular, intravenous | 1MG/5ML (0.2MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 210997, held by EXELA PHARMA SCIENCES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Glyrx-pf NDC codes
Questions
Is there a generic for Glyrx-pf?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Glyrx-pf (glycopyrrolate).
What is the generic name for Glyrx-pf?
The active ingredient in Glyrx-pf 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.
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