FDA Orange Book
Generic for Isuprel
Isuprel contains isoproterenol. 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 Isuprel is isoproterenol. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 6 Isuprel products the Orange Book lists.
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Isuprel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, metered, inhalation | 0.103MG/INH | Discontinued | None | 0 | None |
| injectable, injection | 0.2MG/ML | Discontinued | None | 12 | AP |
| solution, inhalation | 0.5% | Discontinued | None | 0 | None |
| solution, inhalation | 1% | Discontinued | None | 0 | None |
| tablet, rectal, sublingual | 10MG | Discontinued | None | 0 | None |
| tablet, rectal, sublingual | 15MG | Discontinued | None | 0 | None |
NDA 011178, 010515, 006327, 006328, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic isoproterenol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NEXUS PHARMACEUTICALS LLC | 206961 | AP (A-rated, therapeutically equivalent) | August 2, 2017 | 0.2MG/ML |
| AMPHASTAR PHARMACEUTICALS INC | 210106 | AP (A-rated, therapeutically equivalent) | June 18, 2018 | 0.2MG/ML |
| AMNEAL EU LTD | 210576 | AP (A-rated, therapeutically equivalent) | October 17, 2018 | 0.2MG/ML |
| MICRO LABS LTD | 210845 | AP (A-rated, therapeutically equivalent) | February 16, 2021 | 0.2MG/ML |
| J MOLNER HOLDINGS INC | 211237 | AP (A-rated, therapeutically equivalent) | May 19, 2021 | 0.2MG/ML |
| AVET LIFESCIENCES LTD | 212189 | AP (A-rated, therapeutically equivalent) | November 19, 2021 | 0.2MG/ML |
| PENN LIFE SCIENCES LLC | 215542 | AP (A-rated, therapeutically equivalent) | September 20, 2022 | 0.2MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 211703 | AP (A-rated, therapeutically equivalent) | April 26, 2023 | 0.2MG/ML |
| SOMERSET THERAPEUTICS LLC | 211590 | AP (A-rated, therapeutically equivalent) | August 6, 2024 | 0.2MG/ML |
| GLAND PHARMA LTD | 217648 | AP (A-rated, therapeutically equivalent) | October 3, 2024 | 0.2MG/ML |
| DEVA HOLDING AS | 213305 | AP (A-rated, therapeutically equivalent) | December 10, 2025 | 0.2MG/ML |
| ASPIRO PHARMA LTD | 220299 | AP (A-rated, therapeutically equivalent) | May 18, 2026 | 0.2MG/ML |
Questions
Is there a generic for Isuprel?
Yes. The generic name for Isuprel is isoproterenol. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 6 Isuprel products the Orange Book lists.
What is the generic name for Isuprel?
The active ingredient in Isuprel is isoproterenol, 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.