PROAIR

Product NDC: 64725-5790
11-digit product format: 647255790
Labeler code: 64725
Product ID: 64725-5790_b6f855b9-e909-4163-b6c9-892239ae2a07
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: albuterol sulfate
Dosage form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Labeler: TYA Pharmaceuticals
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: E
Listing certified through: 2017-12-31
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	64725-5790		I	Inactivated by FDA		2026-08-03
excluded package	package	64725-5790	64725-5790-1	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.

Historic NDC status page 1 of 1 · 44 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64725-5790-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64725-5790-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64725-5790-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64725-5790-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64725-5790-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64725-5790-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64725-5790-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64725-5790-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64725-5790-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64725-5790-1	I	Inactivated by FDA	`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	64725-5790-1	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	64725-5790-1	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	64725-5790-1	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	64725-5790-1	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	64725-5790-1	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	64725-5790-1	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	64725-5790-1	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	64725-5790-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64725-5790-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64725-5790-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	64725-5790-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	64725-5790-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64725-5790-1	2020-01-31	C162847	48780-1	9d75b9d0-6526-f424-e053-dadaa90a57ce	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64725-5790-1	PROAIR HFA	200 in 1 INHALER	AEROSOL, METERED	200		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALBUTEROL SULFATE	ACTIVE INGREDIENT	021SEF3731	PROAIR HFA (ALBUTEROL SULFATE) AEROSOL, METERED [TYA PHARMACEUTICALS]	2
ALBUTEROL	ACTIVE MOIETY	QF8SVZ843E	PROAIR HFA (ALBUTEROL SULFATE) AEROSOL, METERED [TYA PHARMACEUTICALS]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROAIR HFA (ALBUTEROL SULFATE) AEROSOL, METERED [TYA PHARMACEUTICALS]	2
NORFLURANE	INACTIVE INGREDIENT	DH9E53K1Y8	PROAIR HFA (ALBUTEROL SULFATE) AEROSOL, METERED [TYA PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64725-5790	PROAIR HFA (ALBUTEROL SULFATE) AEROSOL, METERED [TYA PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20141110_374cbcbb-a37c-4057-b9a9-f70b3fdb803c.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
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	374cbcbb-a37c-4057-b9a9-f70b3fdb803c	2
745752	ProAir HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN	374cbcbb-a37c-4057-b9a9-f70b3fdb803c	2
745752	NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [ProAir]	SBD	374cbcbb-a37c-4057-b9a9-f70b3fdb803c	2
2123072	NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	374cbcbb-a37c-4057-b9a9-f70b3fdb803c	2
745752	200 ACTUAT ProAir 0.09 MG/ACTUAT Metered Dose Inhaler	SY	374cbcbb-a37c-4057-b9a9-f70b3fdb803c	2
2123072	albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAir	SY	374cbcbb-a37c-4057-b9a9-f70b3fdb803c	2
745752	NDA021457 200 ACTUAT ProAir 0.09 MG/ACTUAT Metered Dose Inhaler	SY	374cbcbb-a37c-4057-b9a9-f70b3fdb803c	2
745752	ProAir HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	374cbcbb-a37c-4057-b9a9-f70b3fdb803c	2
745752	ProAir HFA 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) Metered Dose Inhaler, 200 ACTUAT	SY	374cbcbb-a37c-4057-b9a9-f70b3fdb803c	2
745752	ProAir HFA 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	374cbcbb-a37c-4057-b9a9-f70b3fdb803c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64725-5790-1	64725579001	200 in 1 INHALER	Historical