VENTOLIN HFA
- Product NDC
- 72189-016
- Requested package NDC
- 72189-016-08
- 11-digit product format
- 721890016
- Labeler code
- 72189
- Product ID
- 72189-016_a8497acf-b1ce-0a3b-e053-2995a90a870b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- albuterol sulfate
- Dosage form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Labeler
- DIRECT RX
- Application
- NDA020983
- Marketing category
- NDA
- Marketing start
- 2020-06-17
- 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
- 2021-12-31
- 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 package | package | 72189-016 | 72189-016-08 | I | Inactivated by FDA | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020983-001 | VENTOLIN HFA | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | AB3 | RLD, RS | 2001-04-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020983-001 | AB3 |
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 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020983-001 | VENTOLIN HFA | EQ 0.09MG BASE/INH | AEROSOL, METERED / INHALATION | BX | RLD, RS | 2001-04-19 | 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 | N020983-001 | BX | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020983-001 | BX | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020983-001 | BX | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020983-001 | BX | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020983-001 | BX | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020983-001 | BX | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020983-001 | BX | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020983-001 | BX | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020983-001 | BX | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020983-001 | BX | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020983-001 | BX | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020983-001 | BX | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020983-001 | BX | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020983-001 | BX | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020983-001 | BX | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020983-001 | BX | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020983-001 | BX | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020983-001 | BX | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020983-001 | BX | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020983-001 | BX | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020983-001 | BX | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020983-001 | BX | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020983-001 | BX | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020983-001 | BX | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020983-001 | BX | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020983-001 | BX | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020983-001 | BX | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020983-001 | BX | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N020983-001 | BX | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N020983-001 | BX | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020983-001 | BX | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020983-001 | BX | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020983-001 | BX | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020983-001 | BX | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N020983-001 | BX | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N020983-001 | BX | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020983-001 | BX | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N020983-001 | BX | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N020983-001 | BX | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020983-001 | BX | 1 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020983-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-07 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020983-001 | 7832351*PED | 2023-12-19 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020983-001 | 7500444 | 2026-02-26 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020983-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020983-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-07 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020983-001 | 7832351*PED | 2023-12-19 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020983-001 | 7500444 | 2026-02-26 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020983-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020983-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-07 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020983-001 | 7832351*PED | 2023-12-19 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020983-001 | 7500444 | 2026-02-26 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020983-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020983-001 | 7350676*PED | 2019-02-24 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020983-001 | 9861771 | 2020-10-11 | Drug product | 2018-03-14 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020983-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-07 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020983-001 | 7832351*PED | 2023-12-19 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020983-001 | 7500444 | 2026-02-26 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020983-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020983-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-07 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020983-001 | 7832351*PED | 2023-12-19 | Pediatric extension | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020983-001 | 7500444 | 2026-02-26 | Drug product | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020983-001 | 7500444*PED | 2026-08-26 | Pediatric extension | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020983-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-07 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020983-001 | 7832351*PED | 2023-12-19 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020983-001 | 7500444 | 2026-02-26 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020983-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020983-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-07 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020983-001 | 7832351*PED | 2023-12-19 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020983-001 | 7500444 | 2026-02-26 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020983-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020983-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-07 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020983-001 | 7832351*PED | 2023-12-19 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020983-001 | 7500444 | 2026-02-26 | Drug product | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020983-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020983-001 | 9861771 | 2020-10-11 | Drug product | 2018-03-14 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020983-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-07 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020983-001 | 7832351*PED | 2023-12-19 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020983-001 | 7500444 | 2026-02-26 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020983-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N020983-001 | 9861771 | 2020-10-11 | Drug product | 2018-03-14 | c0c555d07b60… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 26005090-31a1-441d-920b-db3101a55d53 | Product name | 3 | 20250221 |
| 1c39b897-7219-42a1-9f3a-ec86cfd7b04b | Product name | 3 | 20250218 |
| 0a278166-c8aa-41b6-b4a5-6ac332bde76a | Product name | 1 | 20230718 |
| c76bcd0f-25eb-471e-b970-1956c95c26c5 | Product name | 1 | 20230425 |
| 36390b75-5438-47d3-af60-732a654e9025 | Product name | 2 | 20220110 |
| 387afa72-0c5a-0d6b-ee2c-60c3506659e8 | Product name | 6 | 20210518 |
| 1b8ea3ec-88bd-98ea-c961-00ae340b5b14 | Product name | 2 | 20200220 |
| 3aa5a017-61e9-0c89-adef-13e7964d22f0 | Product name | 3 | 20171208 |
| c3c27a99-b8bc-4955-841c-26555f58ee7e | Product name | 1 | 20150421 |
| bc98cf6f-a973-7162-5e30-0e7dd8c56bc3 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72189-016-08 | 2023-01-30 | C162847 | 48780-1 | f386c64a-030f-0266-e053-dadaa90a7c1a | VENTOLIN HFA |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72189-016-08 | VENTOLIN HFA | 90 in 1 BOTTLE | AEROSOL, METERED | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72189-016-08 | GM - Gram | 72189-016 | 304c7bce-16ea-4273-ba9e-136ba2baf6a8 | 1 | 2020-07-13 |
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 Sulate HFA | ALBUTEROL SULFATE | REMEDYREPACK INC. | 77d34a3c-ccc6-420a-ad31-a1af55f7de76 | 2026-01-30 | Warnings, Adverse reactions | 020983 NDA020983 |
| VENTOLIN HFA | ALBUTEROL SULFATE | REMEDYREPACK INC. | 2ed73618-be3a-4331-9509-6401258f791f | 2026-01-19 | Warnings, Adverse reactions | 020983 NDA020983 |
| VENTOLIN HFA | ALBUTEROL SULFATE | REMEDYREPACK INC. | adb8d669-b91c-46f1-8a86-19f504840eff | 2026-01-14 | Warnings, Adverse reactions | 020983 NDA020983 |
| Albuterol Sulate HFA | ALBUTEROL SULFATE | NuCare Pharmaceuticals,Inc. | 825975b1-a4a9-78ca-e053-2a91aa0a3948 | 2025-09-02 | Warnings, Adverse reactions | 020983 NDA020983 |
| Albuterol Sulfate HFA | ALBUTEROL SULFATE | Advanced Rx of Tennessee, LLC | 04c8a345-0a0d-5a01-e063-6294a90a40d2 | 2024-12-31 | Warnings, Adverse reactions | 020983 NDA020983 |
| VENTOLIN HFA | ALBUTEROL SULFATE | NuCare Pharmaceuticals,Inc. | 7043bc12-8a58-8ff8-e053-2a91aa0ab627 | 2024-07-16 | Warnings, Adverse reactions | 020983 NDA020983 |
| VENTOLIN HFA | ALBUTEROL SULFATE | NuCare Pharmaceuticals,Inc. | 54d90668-5237-4330-e054-00144ff88e88 | 2024-07-15 | Warnings, Adverse reactions | 020983 NDA020983 |
| VENTOLIN HFA | ALBUTEROL SULFATE | A-S Medication Solutions | aa6d5c00-46a5-4f93-95e4-09319abfe71e | 2024-05-07 | Warnings, Adverse reactions | 020983 NDA020983 |
| VENTOLIN HFA | ALBUTEROL SULFATE | A-S Medication Solutions | aff836e4-34f2-4ab9-bbf8-0c41ac848cb0 | 2024-05-07 | Warnings, Adverse reactions | 020983 NDA020983 |
| Albuterol Sulfate HFA | ALBUTEROL SULFATE | Prasco Laboratories | b25d9d6b-eb4c-452e-89ef-10e611deebd6 | 2024-04-30 | Warnings, Adverse reactions | 020983 NDA020983 |
| VENTOLIN HFA | ALBUTEROL SULFATE | GlaxoSmithKline LLC | d92c5d6b-ff10-4087-36a2-1cfc464cb967 | 2024-04-26 | Warnings, Adverse reactions | 020983 NDA020983 |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | HF Acquisition Co LLC, DBA HealthFirst | 767a1504-1e04-1e06-e053-2a91aa0aa4b6 | 2024-02-22 | Warnings, Adverse reactions | 020983 NDA020983 |
| VENTOLIN HFA | ALBUTEROL SULFATE | Proficient Rx LP | 6dc143e7-6bab-42c8-b3e9-9d604d202e73 | 2023-10-01 | Warnings, Adverse reactions | 020983 NDA020983 |
| albuterol sulfate HFA | ALBUTEROL SULFATE | A-S Medication Solutions | 4378c5b0-529f-44b4-bdf1-e9f2631df8cd | 2023-02-06 | Warnings, Adverse reactions | 020983 NDA020983 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 801092 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for Ventolin | PSN | a8497acf-b1cd-0a3b-e053-2995a90a870b | 1 |
| 801095 | Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 60 Actuations | PSN | a8497acf-b1cd-0a3b-e053-2995a90a870b | 1 |
| 801095 | NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin] | SBD | a8497acf-b1cd-0a3b-e053-2995a90a870b | 1 |
| 801092 | NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | a8497acf-b1cd-0a3b-e053-2995a90a870b | 1 |
| 801092 | albuterol 0.09 MG/ACTUAT 60 ACTUAT Metered Dose Inhaler | SY | a8497acf-b1cd-0a3b-e053-2995a90a870b | 1 |
| 801092 | albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler | SY | a8497acf-b1cd-0a3b-e053-2995a90a870b | 1 |
| 801092 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for Ventolin | SY | a8497acf-b1cd-0a3b-e053-2995a90a870b | 1 |
| 801095 | NDA020983 60 ACTUAT Ventolin 0.09 MG/ACTUAT Metered Dose Inhaler | SY | a8497acf-b1cd-0a3b-e053-2995a90a870b | 1 |
| 801095 | Ventolin HFA 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler | SY | a8497acf-b1cd-0a3b-e053-2995a90a870b | 1 |
| 801095 | Ventolin HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 60 ACTUAT | SY | a8497acf-b1cd-0a3b-e053-2995a90a870b | 1 |
| 801095 | Ventolin HFA 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler | SY | a8497acf-b1cd-0a3b-e053-2995a90a870b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72189-016-08 | 72189001608 | 90 AEROSOL, METERED in 1 BOTTLE (72189-016-08) | 2020-06-17 | 0000-00-00 | No | No | Current |