Albuterol sulfate
- Product NDC
- 53002-1554
- 11-digit product format
- 530021554
- Labeler code
- 53002
- Product ID
- 53002-1554_720b8cd6-9581-42c5-82b2-c2a7953f77b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Albuterol sulfate
- Dosage form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA209954
- Marketing category
- ANDA
- Marketing start
- 2020-08-25
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 53002-1554 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 53002-1554 | 53002-1554-1 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53002-1554-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53002-1554-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53002-1554-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53002-1554-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53002-1554-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53002-1554-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53002-1554-1 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53002-1554-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53002-1554-1 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209954-001 | ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209954-001 | 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 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | c0c555d07b60… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209954-001 | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB2 | 2020-08-24 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209954-001 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209954-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209954-001 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209954-001 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209954-001 | AB2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209954-001 | AB2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209954-001 | AB2 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209954-001 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209954-001 | AB2 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209954-001 | AB2 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209954-001 | AB2 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209954-001 | AB2 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209954-001 | AB2 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A209954-001 | AB2 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209954-001 | AB2 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A209954-001 | AB2 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A209954-001 | AB2 | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A209954-001 | AB2 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A209954-001 | AB2 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209954-001 | AB2 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A209954-001 | AB2 | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A209954-001 | AB2 | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A209954-001 | AB2 | 1 | c0c555d07b60… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209954-001 | AB2 | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A209954-001 | AB2 | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A209954-001 | AB2 | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209954-001 | AB2 | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209954-001 | AB2 | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209954-001 | AB2 | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209954-001 | AB2 | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A209954-001 | AB2 | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A209954-001 | AB2 | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209954-001 | AB2 | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A209954-001 | AB2 | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A209954-001 | AB2 | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A209954-001 | AB2 | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209954-001 | AB2 | 1 | a50c72e98297… |
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 | ALBUTEROL SULFATE | Sportpharm LLC | 32d954ee-9790-4beb-95db-72dbf8efa639 | 2026-04-24 | Warnings, Adverse reactions | 209954 ANDA209954 |
| Albuterol sulfate | ALBUTEROL SULFATE | REMEDYREPACK INC. | 0cfb6c5d-eac2-4a1c-8a0f-6b00e819adda | 2026-04-13 | Warnings, Adverse reactions | 209954 ANDA209954 |
| Albuterol sulfate | ALBUTEROL SULFATE | Preferred Pharmaceuticals, Inc. | 99782bc8-56d9-41f8-935e-0d0de27f0c34 | 2025-05-19 | Warnings, Adverse reactions | 209954 ANDA209954 |
| Albuterol sulfate | ALBUTEROL SULFATE | Asclemed USA, Inc. | 264e2145-c7d4-4f4f-aa5b-9fe48a7c5b47 | 2025-05-07 | Warnings, Adverse reactions | 209954 ANDA209954 |
| Albuterol sulfate | ALBUTEROL SULFATE | Lupin Pharmaceuticals, Inc. | 973b8686-c6ce-4280-85c4-c1e7ceab3c09 | 2025-01-23 | Warnings, Adverse reactions | 209954 ANDA209954 |
| Albuterol sulfate | ALBUTEROL SULFATE | A-S Medication Solutions | 52e209ac-7156-4496-ba5a-42ee59d45deb | 2025-01-22 | Warnings, Adverse reactions | 209954 ANDA209954 |
| Albuterol Sulfate | ALBUTEROL SULFATE | Advanced Rx Pharmacy of Tennessee, LLC | f44b325d-0f74-552c-e053-2995a90ac1c9 | 2024-12-31 | Warnings, Adverse reactions | 209954 ANDA209954 |
| Albuterol sulfate | ALBUTEROL SULFATE | NuCare Pharmaceuticals,Inc. | b478d9e9-9704-6af2-e053-2995a90aafd4 | 2024-07-17 | Warnings, Adverse reactions | 209954 ANDA209954 |
| Albuterol sulfate | ALBUTEROL SULFATE | Proficient Rx LP | 4100bce5-096c-42e4-9e4e-d11a0ab597d5 | 2023-01-01 | Warnings, Adverse reactions | 209954 ANDA209954 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-1554-1 | 53002155401 | 1 CANISTER in 1 CARTON (53002-1554-1) > 200 AEROSOL, METERED in 1 CANISTER | 1 canister | 2022-10-01 | 0000-00-00 | No | No | Current |