FDA Orange Book
Generic for Robinul
Robinul 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 Robinul is glycopyrrolate. 27 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP.
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Robinul products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 0.2MG/ML | Marketed (Rx) | AP | 18 | AP |
| injectable, injection | 0.2MG/ML | Discontinued | None | 18 | AP |
| tablet, oral | 1MG | Marketed (Rx) | AA | 12 | AA |
NDA 017558, 014764, 012827, held by HIKMA PHARMACEUTICALS USA INC. 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 |
|---|---|---|---|---|
| AMERICAN REGENT INC | 089335 | AP (A-rated, therapeutically equivalent) | July 23, 1986 | 0.2MG/ML, 0.2MG/ML |
| PH HEALTH LTD | 040653 | AA (A-rated, therapeutically equivalent) | August 31, 2006 | 1MG |
| CHARTWELL RX SCIENCES LLC | 040847 | AA (A-rated, therapeutically equivalent) | March 21, 2008 | 1MG |
| RISING PHARMA HOLDINGS INC | 040821 | AA (A-rated, therapeutically equivalent) | December 29, 2008 | 1MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 040844 | AA (A-rated, therapeutically equivalent) | August 18, 2009 | 1MG |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 090963 | AP (A-rated, therapeutically equivalent) | September 21, 2011 | 0.2MG/ML, 0.2MG/ML |
| TP ANDA HOLDINGS LLC | 090020 | AA (A-rated, therapeutically equivalent) | October 19, 2011 | 1MG |
| VELZEN PHARMA PVT LTD | 090195 | AA (A-rated, therapeutically equivalent) | September 21, 2012 | 1MG |
| AUROBINDO PHARMA LTD | 202675 | AA (A-rated, therapeutically equivalent) | April 15, 2013 | 1MG |
| REGCON HOLDINGS LLC | 091182 | AA (A-rated, therapeutically equivalent) | February 3, 2014 | 1MG |
| NATCO PHARMA LTD | 091413 | AA (A-rated, therapeutically equivalent) | June 20, 2016 | 1MG |
| APPCO PHARMA LLC | 207201 | AA (A-rated, therapeutically equivalent) | January 3, 2017 | 1MG |
| AMNEAL EU LTD | 208973 | AP (A-rated, therapeutically equivalent) | June 15, 2017 | 0.2MG/ML, 0.2MG/ML |
| SOMERSET THERAPEUTICS LLC | 207639 | AP (A-rated, therapeutically equivalent) | June 23, 2017 | 0.2MG/ML, 0.2MG/ML |
| FRESENIUS KABI USA LLC | 209328 | AP (A-rated, therapeutically equivalent) | October 27, 2017 | 0.2MG/ML, 0.2MG/ML |
| PIRAMAL CRITICAL CARE INC | 210842 | AP (A-rated, therapeutically equivalent) | October 25, 2018 | 0.2MG/ML, 0.2MG/ML |
| FRESENIUS KABI USA LLC | 209024 | AP (A-rated, therapeutically equivalent) | October 31, 2018 | 0.2MG/ML, 0.2MG/ML |
| PRINSTON PHARMACEUTICAL INC | 210927 | AP (A-rated, therapeutically equivalent) | October 31, 2018 | 0.2MG/ML, 0.2MG/ML |
| ALEMBIC PHARMACEUTICALS LTD | 203657 | AA (A-rated, therapeutically equivalent) | November 30, 2018 | 1MG |
| CAPLIN STERILES LTD | 211705 | AP (A-rated, therapeutically equivalent) | March 20, 2019 | 0.2MG/ML, 0.2MG/ML |
| SANDOZ INC | 211334 | AP (A-rated, therapeutically equivalent) | May 14, 2019 | 0.2MG/ML, 0.2MG/ML |
| GLAND PHARMA LTD | 212612 | AP (A-rated, therapeutically equivalent) | September 30, 2019 | 0.2MG/ML, 0.2MG/ML |
| SAGENT PHARMACEUTICALS | 210083 | AP (A-rated, therapeutically equivalent) | February 21, 2020 | 0.2MG/ML, 0.2MG/ML |
| ACCORD HEALTHCARE INC | 213238 | AP (A-rated, therapeutically equivalent) | July 8, 2020 | 0.2MG/ML, 0.2MG/ML |
| MEITHEAL PHARMACEUTICALS INC | 212802 | AP (A-rated, therapeutically equivalent) | July 6, 2021 | 0.2MG/ML, 0.2MG/ML |
| NIVAGEN PHARMACEUTICALS LLC | 212591 | AP (A-rated, therapeutically equivalent) | October 13, 2021 | 0.2MG/ML, 0.2MG/ML |
| AMNEAL EU LTD | 215333 | AP (A-rated, therapeutically equivalent) | October 21, 2022 | 0.2MG/ML, 0.2MG/ML |
| ALEMBIC PHARMACEUTICALS LTD | 214635 | AP (A-rated, therapeutically equivalent) | October 26, 2022 | 0.2MG/ML, 0.2MG/ML |
| OMNIVIUM PHARMACEUTICALS LLC | 212871 | AP (A-rated, therapeutically equivalent) | November 29, 2022 | 0.2MG/ML, 0.2MG/ML |
| QUAGEN PHARMACEUTICALS LLC | 212696 | AA (A-rated, therapeutically equivalent) | July 10, 2024 | 1MG |
Robinul NDC codes
Questions
Is there a generic for Robinul?
Yes. The generic name for Robinul is glycopyrrolate. 27 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP.
What is the generic name for Robinul?
The active ingredient in Robinul 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.