PROAIR

Product NDC: 68071-1525
11-digit product format: 680711525
Labeler code: 68071
Product ID: 68071-1525_a826160c-55c4-3b7d-e053-2a95a90ac1ee
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: 2012-12-03
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-1525		D	Discontinued by firm		2026-08-03
excluded package	package	68071-1525	68071-1525-5	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.

Historic NDC status page 1 of 1 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-1525-5	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-1525-5	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-1525-5	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-1525-5	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-1525-5	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-1525-5	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-1525-5	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-1525-5	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-1525-5	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-1525-5	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-1525-5	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1525-5	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-1525-5	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-1525-5	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-1525-5	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68071-1525-5	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68071-1525-5	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68071-1525-5	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-1525-5	2024-10-31	C162847	48780-1	d6a99b39-dbee-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use PROAIR HFA safely and effectively. See full prescribing information for PROAIR HFA Inhalation Aerosol PROAIR HFA (albuterol sulfate) INHALATION AEROSOL Initial U.S. Approval: 1981
68071-1525-5	2022-01-28	C162847	48780-1	d6a99b39-dbee-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use PROAIR HFA safely and effectively. See full prescribing information for PROAIR HFA Inhalation Aerosol PROAIR HFA (albuterol sulfate) INHALATION AEROSOL Initial U.S. Approval: 1981

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68071-1525-5	GM - Gram	68071-1525	5ba3732d-9aa0-4e7c-8981-4225e7932ef9	1	2020-08-06

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1525-5	68071152505	200 AEROSOL, METERED in 1 BOX (68071-1525-5)	2017-08-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROAIR HFA - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2020-06-15	HUMAN PRESCRIPTION DRUG LABEL	3