Proventil HFA

Product NDC: 0085-1132
11-digit product format: 000851132
Labeler code: 0085
Product ID: 0085-1132_bd0c720f-c140-401e-e053-2a95a90a970d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albuterol Sulfate
Dosage form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Labeler: Merck Sharp & Dohme Corp.
Application: NDA020503
Marketing category: NDA
Marketing start: 2018-03-08
Marketing end: 2022-07-31
Substance: ALBUTEROL SULFATE
Active strength: 108 ug/1
Pharmacologic classes: Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0085-1132		I	Inactivated by FDA	2026-08-03
excluded product	product	0085-1132		D	Discontinued by firm	2026-08-03
excluded package	package	0085-1132	0085-1132-01	D	Discontinued by firm	2026-08-03
excluded package	package	0085-1132	0085-1132-02	D	Discontinued by firm	2026-08-03
excluded package	package	0085-1132	0085-1132-04	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 2 · 68 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0085-1132		I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0085-1132		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0085-1132	0085-1132-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0085-1132	0085-1132-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0085-1132	0085-1132-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	0085-1132		I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	0085-1132		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0085-1132	0085-1132-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0085-1132	0085-1132-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0085-1132	0085-1132-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	0085-1132		I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	0085-1132		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0085-1132	0085-1132-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0085-1132	0085-1132-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0085-1132	0085-1132-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	0085-1132		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	0085-1132		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0085-1132	0085-1132-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0085-1132	0085-1132-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0085-1132	0085-1132-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	0085-1132		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	0085-1132		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0085-1132	0085-1132-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0085-1132	0085-1132-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0085-1132	0085-1132-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	0085-1132		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	0085-1132		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0085-1132	0085-1132-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0085-1132	0085-1132-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0085-1132	0085-1132-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	0085-1132		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	0085-1132		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0085-1132	0085-1132-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0085-1132	0085-1132-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0085-1132	0085-1132-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	0085-1132		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	0085-1132		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0085-1132	0085-1132-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0085-1132	0085-1132-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0085-1132	0085-1132-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	0085-1132		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	0085-1132		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0085-1132	0085-1132-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0085-1132	0085-1132-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0085-1132	0085-1132-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	0085-1132		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	0085-1132		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0085-1132	0085-1132-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0085-1132	0085-1132-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0085-1132	0085-1132-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	0085-1132		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	0085-1132		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0085-1132	0085-1132-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0085-1132	0085-1132-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0085-1132	0085-1132-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	0085-1132		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	0085-1132		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0085-1132	0085-1132-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0085-1132	0085-1132-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0085-1132	0085-1132-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N020503-001	PROVENTIL-HFA	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020503-001	AB1

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	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	1996-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	1996-08-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	1996-08-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	1996-08-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`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	N020503-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020503-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020503-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020503-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020503-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020503-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020503-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020503-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020503-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020503-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020503-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020503-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020503-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020503-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020503-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020503-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020503-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020503-001	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020503-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020503-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020503-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020503-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020503-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020503-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020503-001	BX	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020503-001	BX	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020503-001	BX	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020503-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020503-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020503-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020503-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020503-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020503-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020503-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020503-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020503-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020503-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020503-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020503-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020503-001	AB1	1	`cb3db0bc1861…`

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	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	d6acb5a7-555a-463a-ae65-2911d6789b42	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020503 application number: NDA020503
Albuterol Sulfate	ALBUTEROL SULFATE	Sandoz Inc	f8a2c4b7-a162-48ab-90b0-350e4da25c66	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020503 application number: NDA020503
Albuterol Sulfate	ALBUTEROL SULFATE	REMEDYREPACK INC.	32dbec5e-044a-40b6-9b88-e1396c4b4b6e	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020503 application number: NDA020503
Albuterol Sulfate	ALBUTEROL SULFATE	Proficient Rx LP	07b1ee8b-d920-49dd-9fad-cb0fe8a35e0d	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020503 application number: NDA020503

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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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
0085-1132-01	2020-09-27	C162847	48780-1	ab0e2407-28cc-f274-e053-dbdaa90a6471	PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol
0085-1132-02	2020-09-27	C162847	48780-1	ab0e2407-28cc-f274-e053-dbdaa90a6471	PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol
0085-1132-01	2020-09-25	C162847	48780-1	ab0e2407-28cc-f274-e053-dbdaa90a6471	PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol
0085-1132-02	2020-09-25	C162847	48780-1	ab0e2407-28cc-f274-e053-dbdaa90a6471	PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol
0085-1132-01	2020-07-22	C162847	48780-1	ab0e2407-28cc-f274-e053-dbdaa90a6471	PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol
0085-1132-02	2020-07-22	C162847	48780-1	ab0e2407-28cc-f274-e053-dbdaa90a6471	PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0085-1132-01	Proventil HFA	200 in 1 CANISTER	AEROSOL, METERED	200	17
0085-1132-01	Proventil HFA	1 in 1 CARTON	AEROSOL, METERED	1	17
0085-1132-02	Proventil HFA	1 in 1 CARTON	AEROSOL, METERED	1	17
0085-1132-02	Proventil HFA	100 in 1 CANISTER	AEROSOL, METERED	100	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0085-1132-01	GM - Gram	0085-1132	fa80753f-7d15-4873-8c95-c745c17e403b	1	2012-07-24
0085-1132-04	GM - Gram	0085-1132	3c4c0380-71be-4d30-a1f1-53a15fe21a6f	1	2018-04-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Albuterol Sulfate	ACTIVE INGREDIENT	021SEF3731	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [MERCK SHARP & DOHME CORP.]	11
Albuterol	ACTIVE MOIETY	QF8SVZ843E	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [MERCK SHARP & DOHME CORP.]	11
alcohol	INACTIVE INGREDIENT	3K9958V90M	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [MERCK SHARP & DOHME CORP.]	11
NORFLURANE	INACTIVE INGREDIENT	DH9E53K1Y8	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [MERCK SHARP & DOHME CORP.]	11
Oleic acid	INACTIVE INGREDIENT	2UMI9U37CP	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [MERCK SHARP & DOHME CORP.]	11
Albuterol Sulfate	ACTIVE INGREDIENT	021SEF3731	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [REBEL DISTRIBUTORS CORP.]	1
ALBUTEROL SULFATE	ACTIVE INGREDIENT	021SEF3731	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.]	1
Albuterol	ACTIVE MOIETY	QF8SVZ843E	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [REBEL DISTRIBUTORS CORP.]	1
ALBUTEROL	ACTIVE MOIETY	QF8SVZ843E	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [REBEL DISTRIBUTORS CORP.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.]	1
Norflurane	INACTIVE INGREDIENT	DH9E53K1Y8	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [REBEL DISTRIBUTORS CORP.]	1
Oleic acid	INACTIVE INGREDIENT	2UMI9U37CP	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [REBEL DISTRIBUTORS CORP.]	1
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0085-1132	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [MERCK SHARP & DOHME CORP.]	17	Legacy NDC, 4 package rows	20191008_f454947c-6055-474b-bf35-29a379e01aa3.zip

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
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	PSN	f454947c-6055-474b-bf35-29a379e01aa3	17
746763	Proventil HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN	f454947c-6055-474b-bf35-29a379e01aa3	17
746763	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Proventil]	SBD	f454947c-6055-474b-bf35-29a379e01aa3	17
2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	f454947c-6055-474b-bf35-29a379e01aa3	17
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	SY	f454947c-6055-474b-bf35-29a379e01aa3	17
746763	NDA020503 200 ACTUAT Proventil 0.09 MG/ACTUAT Metered Dose Inhaler	SY	f454947c-6055-474b-bf35-29a379e01aa3	17
746763	Proventil 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 200 ACTUAT Metered Dose Inhaler	SY	f454947c-6055-474b-bf35-29a379e01aa3	17
746763	Proventil HFA 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	f454947c-6055-474b-bf35-29a379e01aa3	17
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	PSN	12d06309-0483-48c6-a9f2-b25dcc31db72	1
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	PSN	cb4f1002-9372-4fac-aea3-99142f93dd37	1
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	PSN	1c16cecd-8e1d-43b2-87e9-6d79a81c26a1	1
746763	Proventil HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN	12d06309-0483-48c6-a9f2-b25dcc31db72	1
746763	Proventil HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN	cb4f1002-9372-4fac-aea3-99142f93dd37	1
746763	Proventil HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN	1c16cecd-8e1d-43b2-87e9-6d79a81c26a1	1
746763	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Proventil]	SBD	12d06309-0483-48c6-a9f2-b25dcc31db72	1
746763	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Proventil]	SBD	cb4f1002-9372-4fac-aea3-99142f93dd37	1
746763	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Proventil]	SBD	1c16cecd-8e1d-43b2-87e9-6d79a81c26a1	1
2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	1c16cecd-8e1d-43b2-87e9-6d79a81c26a1	1
2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	12d06309-0483-48c6-a9f2-b25dcc31db72	1
2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	cb4f1002-9372-4fac-aea3-99142f93dd37	1
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	SY	cb4f1002-9372-4fac-aea3-99142f93dd37	1
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	SY	1c16cecd-8e1d-43b2-87e9-6d79a81c26a1	1
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	SY	12d06309-0483-48c6-a9f2-b25dcc31db72	1
746763	NDA020503 200 ACTUAT Proventil 0.09 MG/ACTUAT Metered Dose Inhaler	SY	cb4f1002-9372-4fac-aea3-99142f93dd37	1
746763	NDA020503 200 ACTUAT Proventil 0.09 MG/ACTUAT Metered Dose Inhaler	SY	1c16cecd-8e1d-43b2-87e9-6d79a81c26a1	1
746763	NDA020503 200 ACTUAT Proventil 0.09 MG/ACTUAT Metered Dose Inhaler	SY	12d06309-0483-48c6-a9f2-b25dcc31db72	1
746763	Proventil 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 200 ACTUAT Metered Dose Inhaler	SY	cb4f1002-9372-4fac-aea3-99142f93dd37	1
746763	Proventil 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 200 ACTUAT Metered Dose Inhaler	SY	1c16cecd-8e1d-43b2-87e9-6d79a81c26a1	1
746763	Proventil 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 200 ACTUAT Metered Dose Inhaler	SY	12d06309-0483-48c6-a9f2-b25dcc31db72	1
746763	Proventil HFA 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	12d06309-0483-48c6-a9f2-b25dcc31db72	1
746763	Proventil HFA 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	cb4f1002-9372-4fac-aea3-99142f93dd37	1
746763	Proventil HFA 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	1c16cecd-8e1d-43b2-87e9-6d79a81c26a1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0085-1132-01	00085113201	200 in 1 CANISTER						Historical
0085-1132-02	00085113202	1 in 1 CARTON						Historical
0085-1132-04	00085113204	1 CANISTER in 1 CARTON (0085-1132-04) > 200 AEROSOL, METERED in 1 CANISTER	1 canister	2018-03-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROVENTIL ® HFA (albuterol sulfate) Inhalation Aerosol with Dose Indicator	Merck Sharp & Dohme Corp. \| Kindeva Drug Delivery L.P. \| Kindeva Drug Delivery Limited	2021-03-08	HUMAN PRESCRIPTION DRUG LABEL	7
PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol	Merck Sharp & Dohme Corp. \| 3M Drug Delivery Systems \| 3M Health Care LTD	2019-10-07	HUMAN PRESCRIPTION DRUG LABEL	17
PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol	A-S Medication Solutions	2019-06-13	HUMAN PRESCRIPTION DRUG LABEL	1
PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol	A-S Medication Solutions	2017-12-22	HUMAN PRESCRIPTION DRUG LABEL	15
PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol	Rebel Distributors Corp.	2011-10-04	HUMAN PRESCRIPTION DRUG LABEL	1
Proventil HFA - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2009-10-30	HUMAN PRESCRIPTION DRUG LABEL	1