Proventil HFA

Product NDC: 42254-004
11-digit product format: 422540004
Labeler code: 42254
Product ID: 42254-004_12d06309-0483-48c6-a9f2-b25dcc31db72
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albuterol Sulfate
Dosage form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Labeler: Rebel Distributors Corp.
Application: NDA020503
Marketing category: NDA
Marketing start: 2001-10-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42254-004		I	Inactivated by FDA		2026-08-17
excluded package	package	42254-004	42254-004-67	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`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	42254-004-67	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42254-004-67	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42254-004-67	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 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
2026-08-18 06:07:40	2026-07	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020503-001	AB1	1	`caaa826d4ba7…`
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…`

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
42254-004-67	2019-09-24	C162847	48780-1	9350213a-3de5-c013-e053-90daa90a1393	PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-004-67	Proventil HFA	200 in 1 CANISTER	AEROSOL, METERED	200		1
42254-004-67	Proventil HFA	1 in 1 CARTON	AEROSOL, METERED	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-004-67	GM - Gram	42254-004	1f36ebce-30b8-4627-b63f-854ed187c088	1	2012-07-24

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 [REBEL DISTRIBUTORS CORP.]	1
Albuterol	ACTIVE MOIETY	QF8SVZ843E	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [REBEL DISTRIBUTORS CORP.]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [REBEL DISTRIBUTORS CORP.]	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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-004	PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 2 package rows	20111118_12d06309-0483-48c6-a9f2-b25dcc31db72.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol Sulfate	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

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	12d06309-0483-48c6-a9f2-b25dcc31db72	1
746763	Proventil HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN	12d06309-0483-48c6-a9f2-b25dcc31db72	1
746763	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Proventil]	SBD	12d06309-0483-48c6-a9f2-b25dcc31db72	1
2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	12d06309-0483-48c6-a9f2-b25dcc31db72	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	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	12d06309-0483-48c6-a9f2-b25dcc31db72	1
746763	Proventil HFA 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	12d06309-0483-48c6-a9f2-b25dcc31db72	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-004-67	42254000467	200 in 1 CANISTER	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol	Rebel Distributors Corp.	2011-10-04	HUMAN PRESCRIPTION DRUG LABEL	1