Albuterol Sulfate

Product NDC: 68071-4940
Requested package NDC: 68071-4940-2
11-digit product format: 680714940
Labeler code: 68071
Product ID: 68071-4940_1b2e1fc4-f5f8-9895-e063-6394a90ad067
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albuterol Sulfate
Dosage form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Labeler: NuCare Pharmaceuticals,Inc.
Application: NDA021457
Marketing category: NDA
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

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.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-4940	68071-4940-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-4940	68071-4940-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-4940	68071-4940-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
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#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
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#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
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#

Patent history page 1 of 9 · 339 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	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 table
Ingredient	Strength
ALBUTEROL SULFATE	90 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
021SEF3731	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2123072	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8c278b6f-d32b-b750-e053-2995a90ad7e9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
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#

Effective, Related label table
Effective	Related label
2024-06-27	These highlights do not include all the information needed to use Albuterol Sulfate HFA safely and effectively. See full prescribing information for Albuterol Sulfate HFA Inhalation Aerosol ALBUTEROL SULFATE HFA INHALATION AEROSOL Initial U.S. Approval: 1981
2023-01-30	These highlights do not include all the information needed to use Albuterol Sulfate HFA safely and effectively. See full prescribing information for Albuterol Sulfate HFA Inhalation Aerosol ALBUTEROL SULFATE HFA INHALATION AEROSOL Initial U.S. Approval: 1981
2021-02-18	These highlights do not include all the information needed to use Albuterol Sulfate HFA safely and effectively. See full prescribing information for Albuterol Sulfate HFA Inhalation Aerosol ALBUTEROL SULFATE HFA INHALATION AEROSOL Initial U.S. Approval: 1981
2021-01-29	These highlights do not include all the information needed to use Albuterol Sulfate HFA safely and effectively. See full prescribing information for Albuterol Sulfate HFA Inhalation Aerosol ALBUTEROL SULFATE HFA INHALATION AEROSOL Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4940-2	Albuterol SulfateHFA	200 in 1 BOX	AEROSOL, METERED	200		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4940	ALBUTEROL SULFATE HFA (ALBUTEROL SULFATE) AEROSOL, METERED [NUCARE PHARMACEUTICALS,INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240629_8c278b6f-d32b-b750-e053-2995a90ad7e9.zip

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.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (NDA): 021457 application number: NDA021457 ndc (package): 68071-4940-2 ndc (product): 68071-4940 ndc11 (package): 68071494002
Albuterol Sulfate HFA	ALBUTEROL SULFATE	Asclemed USA, Inc.	a69489f7-4ffb-4cd1-b2d2-002f48e84f51	2023-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021457 application number: NDA021457
Albuterol Sulfate HFA	ALBUTEROL SULFATE	Proficient Rx LP	d617e361-5c03-45ac-9bbe-0fa418edb19f	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021457 application number: NDA021457
Albuterol Sulfate HFA	ALBUTEROL SULFATE	Teva Pharmaceuticals USA, Inc.	7bb5b6dd-9105-4ee7-b205-ed79cf4b371b	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021457 application number: NDA021457

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
021SEF3731	ALBUTEROL SULFATE	51022-70-9	ALBUTEROL SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2123072	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAir	PSN	8c278b6f-d32b-b750-e053-2995a90ad7e9	4
2123072	NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	8c278b6f-d32b-b750-e053-2995a90ad7e9	4
2123072	albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAir	SY	8c278b6f-d32b-b750-e053-2995a90ad7e9	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4940-2	68071494002	200 AEROSOL, METERED in 1 BOX (68071-4940-2)	2019-06-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Albuterol Sulfate HFA - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-06-18	HUMAN PRESCRIPTION DRUG LABEL	4