Albuterol Sulfate
- Product NDC
- 0093-3174
- 11-digit product format
- 000933174
- Labeler code
- 0093
- Product ID
- 0093-3174_d9fc7dd4-8c8c-4c83-a6b7-02d984f4135b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Albuterol Sulfate
- Dosage form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- NDA021457
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-01-16
- Substance
- ALBUTEROL SULFATE
- Active strength
- 90 ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021457-001 | PROAIR HFA | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021457-001 | AB2 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2004-10-29 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2004-10-29 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2004-10-29 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2004-10-29 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021457-001 | PROAIR HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | RLD, RS | 2004-10-29 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021457-001 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021457-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021457-001 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021457-001 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021457-001 | AB2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021457-001 | AB2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021457-001 | AB2 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021457-001 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021457-001 | AB2 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021457-001 | AB2 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021457-001 | AB2 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021457-001 | AB2 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021457-001 | AB2 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021457-001 | AB2 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021457-001 | AB2 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021457-001 | AB2 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021457-001 | AB2 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021457-001 | BX | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021457-001 | AB2 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021457-001 | AB2 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021457-001 | AB2 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021457-001 | AB2 | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021457-001 | AB2 | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021457-001 | AB2 | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021457-001 | BX | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021457-001 | BX | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021457-001 | BX | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021457-001 | AB2 | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021457-001 | AB2 | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021457-001 | AB2 | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021457-001 | AB2 | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021457-001 | AB2 | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021457-001 | AB2 | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021457-001 | AB2 | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021457-001 | AB2 | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021457-001 | AB2 | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021457-001 | AB2 | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N021457-001 | AB2 | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N021457-001 | AB2 | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021457-001 | AB2 | 1 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | N021457-001 | 10022509 | 2031-05-18 | Drug product | 2018-08-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021457-001 | 10022510 | 2031-05-18 | Drug product | 2018-08-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021457-001 | 10086156 | 2031-05-18 | Drug product | 2018-10-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021457-001 | 10695512 | 2031-05-18 | Drug product | 2020-07-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021457-001 | 8132712 | 2028-09-07 | Drug product | 2012-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021457-001 | 10022509 | 2031-05-18 | Drug product | 2018-08-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021457-001 | 10022510 | 2031-05-18 | Drug product | 2018-08-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021457-001 | 10086156 | 2031-05-18 | Drug product | 2018-10-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021457-001 | 10695512 | 2031-05-18 | Drug product | 2020-07-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021457-001 | 11395889 | 2031-05-18 | Drug product | 2022-08-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021457-001 | 9463289 | 2031-05-18 | Drug product | 2016-11-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021457-001 | 9808587 | 2031-05-18 | Drug product | 2017-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021457-001 | 10561808 | 2032-01-01 | Drug product | 2020-03-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021457-001 | 8132712 | 2028-09-07 | Drug product | 2012-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021457-001 | 10022509 | 2031-05-18 | Drug product | 2018-08-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021457-001 | 10022510 | 2031-05-18 | Drug product | 2018-08-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021457-001 | 10086156 | 2031-05-18 | Drug product | 2018-10-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021457-001 | 10695512 | 2031-05-18 | Drug product | 2020-07-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021457-001 | 11395889 | 2031-05-18 | Drug product | 2022-08-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021457-001 | 9463289 | 2031-05-18 | Drug product | 2016-11-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021457-001 | 9808587 | 2031-05-18 | Drug product | 2017-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021457-001 | 10561808 | 2032-01-01 | Drug product | 2020-03-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021457-001 | 8132712 | 2028-09-07 | Drug product | 2012-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021457-001 | 10022509 | 2031-05-18 | Drug product | 2018-08-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021457-001 | 10022510 | 2031-05-18 | Drug product | 2018-08-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021457-001 | 10086156 | 2031-05-18 | Drug product | 2018-10-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021457-001 | 10695512 | 2031-05-18 | Drug product | 2020-07-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021457-001 | 11395889 | 2031-05-18 | Drug product | 2022-08-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021457-001 | 9463289 | 2031-05-18 | Drug product | 2016-11-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021457-001 | 9808587 | 2031-05-18 | Drug product | 2017-11-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021457-001 | 10561808 | 2032-01-01 | Drug product | 2020-03-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021457-001 | 8132712 | 2028-09-07 | Drug product | 2012-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021457-001 | 10022509 | 2031-05-18 | Drug product | 2018-08-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021457-001 | 10022510 | 2031-05-18 | Drug product | 2018-08-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021457-001 | 10086156 | 2031-05-18 | Drug product | 2018-10-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021457-001 | 10695512 | 2031-05-18 | Drug product | 2020-07-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021457-001 | 11395889 | 2031-05-18 | Drug product | 2022-08-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021457-001 | 9463289 | 2031-05-18 | Drug product | 2016-11-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021457-001 | 9808587 | 2031-05-18 | Drug product | 2017-11-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021457-001 | 10561808 | 2032-01-01 | Drug product | 2020-03-19 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Albuterol Sulfate
- Brand name suffix
- HFA
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ALBUTEROL SULFATE | 90 ug/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 021SEF3731 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2123072 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7bb5b6dd-9105-4ee7-b205-ed79cf4b371b | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0093-3174-31 | Albuterol SulfateHFA | 200 in 1 INHALER | AEROSOL, METERED | 200 | 15 | |
| 0093-3174-31 | Albuterol SulfateHFA | 1 in 1 CARTON | AEROSOL, METERED | 1 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0093-3174-31 | GM - Gram | 0093-3174 | b782a6f5-d54d-48f6-af90-bd547bf78d54 | 1 | 2019-02-13 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Albuterol Sulfate HFA | ALBUTEROL SULFATE | NuCare Pharmaceuticals,Inc. | 8c278b6f-d32b-b750-e053-2995a90ad7e9 | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | 021457 NDA021457 |
| Albuterol Sulfate HFA | ALBUTEROL SULFATE | Asclemed USA, Inc. | a69489f7-4ffb-4cd1-b2d2-002f48e84f51 | 2023-12-19 | Boxed warning, Warnings, Adverse reactions | 021457 NDA021457 |
| Albuterol Sulfate HFA | ALBUTEROL SULFATE | Proficient Rx LP | d617e361-5c03-45ac-9bbe-0fa418edb19f | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | 021457 NDA021457 |
| Albuterol Sulfate HFA | ALBUTEROL SULFATE | Teva Pharmaceuticals USA, Inc. | 7bb5b6dd-9105-4ee7-b205-ed79cf4b371b | 2023-01-31 | Warnings, Adverse reactions | 021457 NDA021457 0093-3174 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2123072 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAir | PSN | 7bb5b6dd-9105-4ee7-b205-ed79cf4b371b | 15 |
| 2123072 | NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | 7bb5b6dd-9105-4ee7-b205-ed79cf4b371b | 15 |
| 2123072 | albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAir | SY | 7bb5b6dd-9105-4ee7-b205-ed79cf4b371b | 15 |
| 2123072 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAir | PSN | d617e361-5c03-45ac-9bbe-0fa418edb19f | 5 |
| 2123072 | NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | d617e361-5c03-45ac-9bbe-0fa418edb19f | 5 |
| 2123072 | albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAir | SY | d617e361-5c03-45ac-9bbe-0fa418edb19f | 5 |
| 2123072 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAir | PSN | 8c278b6f-d32b-b750-e053-2995a90ad7e9 | 4 |
| 2123072 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAir | PSN | a69489f7-4ffb-4cd1-b2d2-002f48e84f51 | 4 |
| 2123072 | NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | 8c278b6f-d32b-b750-e053-2995a90ad7e9 | 4 |
| 2123072 | NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | a69489f7-4ffb-4cd1-b2d2-002f48e84f51 | 4 |
| 2123072 | albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAir | SY | 8c278b6f-d32b-b750-e053-2995a90ad7e9 | 4 |
| 2123072 | albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAir | SY | a69489f7-4ffb-4cd1-b2d2-002f48e84f51 | 4 |
| 313782 | acetaminophen 325 MG Oral Tablet | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 2123076 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for Ventolin | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 2123072 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAir | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 2123111 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 801092 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for Ventolin | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 212033 | aspirin 325 MG Oral Tablet | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1190552 | atropine sulfate 0.5 MG in 5 ML Prefilled Syringe | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1190546 | atropine sulfate 1 MG in 10 ML Prefilled Syringe | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1795514 | dextrose 50 % in 50 ML Injection | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 727517 | dextrose 50 % in 50 ML Prefilled Syringe | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1049633 | diphenhydrAMINE HCl 50 MG/ML Injectable Solution | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1660014 | EPINEPHrine 1 MG in 1 ML Injection | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 727373 | EPINEPHrine 1 MG in 10 ML Prefilled Syringe | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1737761 | lidocaine HCl 2 % in 5 ML Injection | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1012068 | lidocaine HCl 2 % in 5 ML Prefilled Syringe | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 198039 | nitroglycerin 0.4 MG Sublingual Tablet | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 745752 | ProAir HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807632 | sodium chloride 0.9 % in 100 ML Injection | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807639 | sodium chloride 0.9 % in 1000 ML Injection | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807627 | sodium chloride 0.9 % in 150 ML Injection | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807630 | sodium chloride 0.9 % in 25 ML Injection | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807633 | sodium chloride 0.9 % in 250 ML Injection | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807631 | sodium chloride 0.9 % in 50 ML Injection | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807634 | sodium chloride 0.9 % in 500 ML Injection | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 859088 | Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 801095 | Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 60 Actuations | PSN | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 859088 | NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin] | SBD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 801095 | NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin] | SBD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 745752 | NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [ProAir] | SBD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1660014 | 1 ML epinephrine 1 MG/ML Injection | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1190546 | 10 ML atropine sulfate 0.1 MG/ML Prefilled Syringe | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 727373 | 10 ML epinephrine 0.1 MG/ML Prefilled Syringe | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807632 | 100 ML sodium chloride 9 MG/ML Injection | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807639 | 1000 ML sodium chloride 9 MG/ML Injection | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807627 | 150 ML sodium chloride 9 MG/ML Injection | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807630 | 25 ML sodium chloride 9 MG/ML Injection | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807633 | 250 ML sodium chloride 9 MG/ML Injection | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1190552 | 5 ML atropine sulfate 0.1 MG/ML Prefilled Syringe | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1737761 | 5 ML lidocaine hydrochloride 20 MG/ML Injection | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1012068 | 5 ML lidocaine hydrochloride 20 MG/ML Prefilled Syringe | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1795514 | 50 ML glucose 500 MG/ML Injection | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 727517 | 50 ML glucose 500 MG/ML Prefilled Syringe | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807631 | 50 ML sodium chloride 9 MG/ML Injection | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807634 | 500 ML sodium chloride 9 MG/ML Injection | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 313782 | acetaminophen 325 MG Oral Tablet | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 212033 | aspirin 325 MG Oral Tablet | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1049633 | diphenhydramine hydrochloride 50 MG/ML Injectable Solution | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 2123111 | NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 2123076 | NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 801092 | NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 2123072 | NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 198039 | nitroglycerin 0.4 MG Sublingual Tablet | SCD | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807632 | 100 ML NaCl 9 MG/ML Injection | SY | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807639 | 1000 ML NaCl 9 MG/ML Injection | SY | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807627 | 150 ML NaCl 9 MG/ML Injection | SY | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 745752 | 200 ACTUAT ProAir 0.09 MG/ACTUAT Metered Dose Inhaler | SY | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807630 | 25 ML NaCl 9 MG/ML Injection | SY | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807633 | 250 ML NaCl 9 MG/ML Injection | SY | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 727517 | 50 ML dextrose 50 % Prefilled Syringe | SY | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807631 | 50 ML NaCl 9 MG/ML Injection | SY | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 1807634 | 500 ML NaCl 9 MG/ML Injection | SY | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 801092 | albuterol 0.09 MG/ACTUAT 60 ACTUAT Metered Dose Inhaler | SY | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 801092 | albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler | SY | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
| 2123072 | albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAir | SY | 9ef8edbd-047a-40fe-a603-d71fce8ada68 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0093-3174-31 | 00093317431 | 1 INHALER in 1 CARTON (0093-3174-31) / 200 AEROSOL, METERED in 1 INHALER | 1 inhaler | 2019-01-16 | 0000-00-00 | No | No | Current |