FDA Orange Book
Generic for Vazculep
Vazculep contains phenylephrine. 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 Vazculep is phenylephrine. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP1, AP2.
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Vazculep products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 100MG/10ML (10MG/ML) | Discontinued | None | 15 | AP1, AP2 |
| solution, intravenous | 10MG/ML (10MG/ML) | Discontinued | None | 16 | AP2, AP1 |
| solution, intravenous | 50MG/5ML (10MG/ML) | Discontinued | None | 15 | AP1, AP2 |
NDA 204300, 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.
Approved generic phenylephrine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MEITHEAL PHARMACEUTICALS INC | 210333 | AP1 (A-rated, therapeutically equivalent) | April 27, 2018 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| MEITHEAL PHARMACEUTICALS INC | 210334 | AP2 (A-rated, therapeutically equivalent) | April 27, 2018 | 10MG/ML (10MG/ML) |
| AMNEAL EU LTD | 211079 | AP1 (A-rated, therapeutically equivalent) | July 5, 2018 | 10MG/ML (10MG/ML) |
| AMNEAL EU LTD | 211078 | AP1 (A-rated, therapeutically equivalent) | July 19, 2018 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| PH HEALTH LTD | 210025 | AP1 (A-rated, therapeutically equivalent) | December 21, 2018 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| FRESENIUS KABI USA LLC | 210665 | AP2 (A-rated, therapeutically equivalent) | January 29, 2019 | 10MG/ML (10MG/ML) |
| FRESENIUS KABI USA LLC | 210666 | AP1 (A-rated, therapeutically equivalent) | January 30, 2019 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| SANDOZ INC | 208905 | AP1 (A-rated, therapeutically equivalent) | January 31, 2019 | 100MG/10ML (10MG/ML), 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML) |
| SAGENT PHARMACEUTICALS INC | 209967 | AP1 (A-rated, therapeutically equivalent) | January 16, 2020 | 100MG/10ML (10MG/ML), 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML) |
| GLAND PHARMA LTD | 211920 | AP1 (A-rated, therapeutically equivalent) | June 5, 2020 | 100MG/10ML (10MG/ML), 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML) |
| CAPLIN STERILES LTD | 213318 | AP1 (A-rated, therapeutically equivalent) | June 11, 2020 | 100MG/10ML (10MG/ML), 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML) |
| MILLA PHARMACEUTICALS INC | 211081 | AP1 (A-rated, therapeutically equivalent) | July 17, 2020 | 100MG/10ML (10MG/ML), 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 210697 | AP1 (A-rated, therapeutically equivalent) | November 13, 2020 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 210696 | AP2 (A-rated, therapeutically equivalent) | January 7, 2021 | 10MG/ML (10MG/ML) |
| MANKIND PHARMA LTD | 217069 | AP1 (A-rated, therapeutically equivalent) | August 30, 2022 | 100MG/10ML (10MG/ML), 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML) |
| AVET LIFESCIENCES PRIVATE LTD | 209968 | AP2 (A-rated, therapeutically equivalent) | February 28, 2023 | 10MG/ML (10MG/ML) |
| BE PHARMACEUTICALS AG | 217521 | AP2 (A-rated, therapeutically equivalent) | June 26, 2023 | 100MG/10ML (10MG/ML), 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML) |
| HAINAN POLY PHARM CO LTD | 218412 | AP1 (A-rated, therapeutically equivalent) | March 14, 2024 | 100MG/10ML (10MG/ML), 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML) |
| ASPIRO PHARMA LTD | 218110 | AP1 (A-rated, therapeutically equivalent) | May 10, 2024 | 100MG/10ML (10MG/ML), 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML) |
| BAXTER HEALTHCARE CORP | 217032 | AP1 (A-rated, therapeutically equivalent) | April 3, 2026 | 100MG/10ML (10MG/ML), 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML) |
| NEPHRON PHARMACEUTICALS CORPORATION | 215268 | AP2 (A-rated, therapeutically equivalent) | September 24, 2026 | 10MG/ML (10MG/ML) |
Questions
Is there a generic for Vazculep?
Yes. The generic name for Vazculep is phenylephrine. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP1, AP2.
What is the generic name for Vazculep?
The active ingredient in Vazculep is phenylephrine, 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.