VENTOLIN

Product NDC: 35356-166
11-digit product format: 353560166
Labeler code: 35356
Product ID: 35356-166_caf02872-abd7-4ad7-adbb-4fea398c8d9d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: albuterol sulfate
Dosage form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: NDA020983
Marketing category: NDA
Marketing start: 2006-06-09
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: 2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	35356-166		D	Discontinued by firm	2026-08-03
excluded package	package	35356-166	35356-166-01	D	Discontinued by firm	2026-08-03
excluded package	package	35356-166	35356-166-02	D	Discontinued by firm	2026-08-03
excluded package	package	35356-166	35356-166-08	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 · 60 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	35356-166-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-166-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-166-08	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	35356-166-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-166-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-166-08	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	35356-166-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-166-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-166-08	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	35356-166-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-166-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-166-08	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	35356-166-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-166-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-166-08	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	35356-166-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-166-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-166-08	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	35356-166-02	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-166-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-166-08	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	35356-166-02	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-166-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-166-08	D	Discontinued by firm	`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	35356-166-02	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-166-08	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-166-01	D	Discontinued by firm	`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	35356-166-02	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-166-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-166-01	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	35356-166-02	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35356-166-08	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35356-166-01	D	Discontinued by firm	`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	35356-166-02	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35356-166-08	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35356-166-01	D	Discontinued by firm	`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	35356-166-02	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	35356-166-02	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	35356-166-02	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	35356-166-02	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	35356-166-02	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	35356-166-02	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
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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
35356-166-01	2025-01-14	These highlights do not include all the information needed to use VENTOLIN HFA safely and effectively. See full prescribing information for VENTOLIN HFA. VENTOLIN HFA (albuterol sulfate) Inhalation Aerosol FOR ORAL INHALATION Initial U.S. Approval: 1981
35356-166-02	2025-01-14	These highlights do not include all the information needed to use VENTOLIN HFA safely and effectively. See full prescribing information for VENTOLIN HFA. VENTOLIN HFA (albuterol sulfate) Inhalation Aerosol FOR ORAL INHALATION Initial U.S. Approval: 1981
35356-166-08	2025-01-14	These highlights do not include all the information needed to use VENTOLIN HFA safely and effectively. See full prescribing information for VENTOLIN HFA. VENTOLIN HFA (albuterol sulfate) Inhalation Aerosol FOR ORAL INHALATION Initial U.S. Approval: 1981
35356-166-01	2022-01-28	These highlights do not include all the information needed to use VENTOLIN HFA safely and effectively. See full prescribing information for VENTOLIN HFA. VENTOLIN HFA (albuterol sulfate) Inhalation Aerosol FOR ORAL INHALATION Initial U.S. Approval: 1981
35356-166-02	2022-01-28	These highlights do not include all the information needed to use VENTOLIN HFA safely and effectively. See full prescribing information for VENTOLIN HFA. VENTOLIN HFA (albuterol sulfate) Inhalation Aerosol FOR ORAL INHALATION Initial U.S. Approval: 1981
35356-166-08	2022-01-28	These highlights do not include all the information needed to use VENTOLIN HFA safely and effectively. See full prescribing information for VENTOLIN HFA. VENTOLIN HFA (albuterol sulfate) Inhalation Aerosol FOR ORAL INHALATION 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
35356-166-01	GM - Gram	35356-166	0f2f0384-36f4-4b62-beb5-14b8d5340d76	1	2012-07-24
35356-166-02	GM - Gram	35356-166	930f2da3-fa31-4ac4-89f9-d181c5df41a5	1	2018-08-13
35356-166-08	GM - Gram	35356-166	1b99d68a-182a-4fc0-ac14-323e1d876ae4	1	2018-07-03

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 [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3860
ALBUTEROL	ACTIVE MOIETY	QF8SVZ843E	VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3860
NORFLURANE	INACTIVE INGREDIENT	DH9E53K1Y8	VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3860

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
35356-166-02	35356016602	1 INHALER in 1 CARTON (35356-166-02) > 60 AEROSOL, METERED in 1 INHALER	1 inhaler	2018-06-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VENTOLIN HFA - Lake Erie Medical DBA Quality Care Products LLC	Lake Erie Medical DBA Quality Care Products LLC	2019-03-26	HUMAN PRESCRIPTION DRUG LABEL	3864