FDA Orange Book
Generic for Proventil
Proventil contains albuterol. 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 Proventil is albuterol. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AN. Generics match 5 of the 7 Proventil products the Orange Book lists.
Run it in Rivvi
Map Proventil and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Proventil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, metered, inhalation | 0.09MG/INH | Discontinued | None | 0 | None |
| solution, inhalation | EQ 0.083% BASE | Discontinued | None | 4 | AN |
| solution, inhalation | EQ 0.5% BASE | Discontinued | None | 3 | AN |
| syrup, oral | EQ 2MG BASE/5ML | Discontinued | None | 5 | AA |
| tablet, extended release, oral | EQ 4MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 2MG BASE | Discontinued | None | 5 | AB |
| tablet, oral | EQ 4MG BASE | Discontinued | None | 5 | AB |
NDA 017559, 019243, 018062, 019383, 017853, held by SCHERING CORP SUB SCHERING PLOUGH CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic albuterol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES INC | 072637 | AB (A-rated, therapeutically equivalent) | December 5, 1989 | EQ 2MG BASE, EQ 4MG BASE |
| TEVA PHARMACEUTICALS USA INC | 073419 | AA (A-rated, therapeutically equivalent) | March 30, 1992 | EQ 2MG BASE/5ML |
| NEPHRON CORP | 074880 | AN (A-rated, therapeutically equivalent) | September 17, 1997 | EQ 0.083% BASE |
| SENTISS AG | 074543 | AN (A-rated, therapeutically equivalent) | January 15, 1998 | EQ 0.5% BASE |
| NEPHRON CORP | 075664 | AN (A-rated, therapeutically equivalent) | June 26, 2001 | EQ 0.5% BASE |
| CHARTWELL MOLECULAR HOLDINGS LLC | 078105 | AA (A-rated, therapeutically equivalent) | December 27, 2006 | EQ 2MG BASE/5ML |
| CHARTWELL RX SCIENCES LLC | 077788 | AA (A-rated, therapeutically equivalent) | June 26, 2007 | EQ 2MG BASE/5ML |
| THE RITEDOSE CORP | 077839 | AN (A-rated, therapeutically equivalent) | December 16, 2008 | EQ 0.083% BASE |
| AMNEAL PHARMACEUTICALS | 079241 | AA (A-rated, therapeutically equivalent) | May 12, 2010 | EQ 2MG BASE/5ML |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 207857 | AN (A-rated, therapeutically equivalent) | July 21, 2017 | EQ 0.083% BASE |
| LUOXIN AUROVITAS PHARMA CHENGDU CO LTD | 206224 | AN (A-rated, therapeutically equivalent) | October 17, 2017 | EQ 0.083% BASE |
| AMNEAL PHARMACEUTICALS CO GMBH | 208804 | AB (A-rated, therapeutically equivalent) | May 21, 2018 | EQ 2MG BASE, EQ 4MG BASE |
| RISING PHARMA HOLDINGS INC | 207046 | AB (A-rated, therapeutically equivalent) | June 29, 2018 | EQ 2MG BASE, EQ 4MG BASE |
| ACERTIS PHARMACEUTICALS LLC | 211397 | AB (A-rated, therapeutically equivalent) | October 26, 2018 | EQ 2MG BASE, EQ 4MG BASE |
| QUAGEN PHARMACEUTICALS LLC | 212197 | AA (A-rated, therapeutically equivalent) | September 6, 2019 | EQ 2MG BASE/5ML |
| ZYDUS PHARMACEUTICALS USA INC | 208884 | AB (A-rated, therapeutically equivalent) | October 22, 2020 | EQ 2MG BASE, EQ 4MG BASE |
| THE RITEDOSE CORP | 218386 | AN (A-rated, therapeutically equivalent) | March 12, 2025 | EQ 0.5% BASE |
Questions
Is there a generic for Proventil?
Yes. The generic name for Proventil is albuterol. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AN. Generics match 5 of the 7 Proventil products the Orange Book lists.
What is the generic name for Proventil?
The active ingredient in Proventil is albuterol, 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.