VENTOLIN

Product NDC: 52959-983
11-digit product format: 529590983
Labeler code: 52959
Product ID: 52959-983_be7d9791-f676-426c-ba46-6dbaced723af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: albuterol sulfate
Dosage form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Labeler: H.J. Harkins Company, Inc.
Application: NDA020983
Marketing category: NDA
Marketing start: 2006-06-09
Marketing end: 0000-00-00
Substance: ALBUTEROL SULFATE
Active strength: 108 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-983		I	Inactivated by FDA	2026-08-03
excluded package	package	52959-983	52959-983-08	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-983	52959-983-18	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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-983-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-983-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-983-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-983-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-983-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-983-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-983-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-983-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-983-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-983-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-983-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-983-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-983-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-983-18	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-983-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-983-18	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-983-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-983-18	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-983-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-983-18	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-983-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-983-18	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-983-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-983-18	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-983-08	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-983-18	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-983-08	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-983-18	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-983-08	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-983-18	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52959-983-08	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52959-983-18	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52959-983-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52959-983-18	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52959-983-08	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52959-983-18	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52959-983-08	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52959-983-18	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52959-983-08	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52959-983-18	`e2bbac7714bc…`	`27bdfed8d636…`

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
N020983-001	VENTOLIN HFA	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB3	RLD, RS	2001-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
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.

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	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#

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	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#

Patent history page 1 of 3 · 106 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	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 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
52959-983-08	2019-11-13	C162847	48780-1	97449f38-cc77-f6ea-e053-dbdaa90aa703	These highlights do not include all the information needed to use VENTOLIN HFA Inhalation Aerosol safely and effectively. See full prescribing information for VENTOLIN HFA Inhalation Aerosol. VENTOLIN ® HFA (albuterol sulfate) Inhalation Aerosol Initial U.S. Approval: 1981
52959-983-18	2019-11-13	C162847	48780-1	97449f38-cc77-f6ea-e053-dbdaa90aa703	These highlights do not include all the information needed to use VENTOLIN HFA Inhalation Aerosol safely and effectively. See full prescribing information for VENTOLIN HFA Inhalation Aerosol. VENTOLIN ® 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
52959-983-08	VENTOLINHFA	60 in 1 INHALER	AEROSOL, METERED	60		3
52959-983-18	VENTOLINHFA	200 in 1 INHALER	AEROSOL, METERED	200		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALBUTEROL SULFATE	ACTIVE INGREDIENT	021SEF3731	VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [H.J. HARKINS COMPANY, INC.]	3
ALBUTEROL	ACTIVE MOIETY	QF8SVZ843E	VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [H.J. HARKINS COMPANY, INC.]	3
NORFLURANE	INACTIVE INGREDIENT	DH9E53K1Y8	VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [H.J. HARKINS COMPANY, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-983	VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [H.J. HARKINS COMPANY, INC.]	3	Legacy NDC, 2 package rows	20120123_77f24a8c-0a9a-4708-a401-3f56b5d4f2c1.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 · 14 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (NDA): 020983 application number: NDA020983
VENTOLIN HFA	ALBUTEROL SULFATE	REMEDYREPACK INC.	2ed73618-be3a-4331-9509-6401258f791f	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983
VENTOLIN HFA	ALBUTEROL SULFATE	REMEDYREPACK INC.	adb8d669-b91c-46f1-8a86-19f504840eff	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983
Albuterol Sulate HFA	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	825975b1-a4a9-78ca-e053-2a91aa0a3948	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983
Albuterol Sulfate HFA	ALBUTEROL SULFATE	Advanced Rx of Tennessee, LLC	04c8a345-0a0d-5a01-e063-6294a90a40d2	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983
VENTOLIN HFA	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	7043bc12-8a58-8ff8-e053-2a91aa0ab627	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983
VENTOLIN HFA	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	54d90668-5237-4330-e054-00144ff88e88	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983
VENTOLIN HFA	ALBUTEROL SULFATE	A-S Medication Solutions	aa6d5c00-46a5-4f93-95e4-09319abfe71e	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983
VENTOLIN HFA	ALBUTEROL SULFATE	A-S Medication Solutions	aff836e4-34f2-4ab9-bbf8-0c41ac848cb0	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983
Albuterol Sulfate HFA	ALBUTEROL SULFATE	Prasco Laboratories	b25d9d6b-eb4c-452e-89ef-10e611deebd6	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983
VENTOLIN HFA	ALBUTEROL SULFATE	GlaxoSmithKline LLC	d92c5d6b-ff10-4087-36a2-1cfc464cb967	2024-04-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983
ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	767a1504-1e04-1e06-e053-2a91aa0aa4b6	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983
VENTOLIN HFA	ALBUTEROL SULFATE	Proficient Rx LP	6dc143e7-6bab-42c8-b3e9-9d604d202e73	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983
albuterol sulfate HFA	ALBUTEROL SULFATE	A-S Medication Solutions	4378c5b0-529f-44b4-bdf1-e9f2631df8cd	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983

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
2123076	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for Ventolin	PSN	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
801092	albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for Ventolin	PSN	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
859088	Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
801095	Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 60 Actuations	PSN	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
859088	NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin]	SBD	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
801095	NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin]	SBD	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
2123076	NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
801092	NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
801092	albuterol 0.09 MG/ACTUAT 60 ACTUAT Metered Dose Inhaler	SY	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
801092	albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler	SY	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
2123076	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for Ventolin	SY	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
801092	albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for Ventolin	SY	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
859088	NDA020983 200 ACTUAT Ventolin 0.09 MG/ACTUAT Metered Dose Inhaler	SY	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
801095	NDA020983 60 ACTUAT Ventolin 0.09 MG/ACTUAT Metered Dose Inhaler	SY	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
801095	Ventolin HFA 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler	SY	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
859088	Ventolin HFA 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) Metered Dose Inhaler, 200 ACTUAT	SY	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
859088	Ventolin HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
801095	Ventolin HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3
801095	Ventolin HFA 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler	SY	77f24a8c-0a9a-4708-a401-3f56b5d4f2c1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-983-08	52959098308	60 in 1 INHALER	Historical
52959-983-18	52959098318	200 in 1 INHALER	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VENTOLIN HFA - H.J. Harkins Company, Inc.	H.J. Harkins Company, Inc.	2012-01-20	HUMAN PRESCRIPTION DRUG LABEL	3