Albuterol Sulfate

Product NDC: 21695-332
11-digit product format: 216950332
Labeler code: 21695
Product ID: 21695-332_fd41a51d-d569-4368-a3b1-a12cb2472754
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albuterol Sulfate
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Rebel Distributors Corp.
Application: ANDA074880
Marketing category: ANDA
Marketing start: 1997-09-17
Marketing end: 0000-00-00
Substance: ALBUTEROL SULFATE
Active strength: 3 mg/3mL
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	21695-332		I	Inactivated by FDA	2026-08-03
excluded package	package	21695-332	21695-332-25	I	Inactivated by FDA	2026-08-03
excluded package	package	21695-332	21695-332-30	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	21695-332-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-332-30	`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	21695-332-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-332-30	`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	21695-332-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-332-30	`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	21695-332-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-332-30	`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	21695-332-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-332-30	`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	21695-332-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-332-30	`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	21695-332-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-332-30	`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	21695-332-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-332-30	`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	21695-332-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-332-30	`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	21695-332-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-332-30	`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	21695-332-25	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-332-30	`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	21695-332-25	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-332-30	`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	21695-332-25	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-332-30	`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	21695-332-25	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-332-30	`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	21695-332-25	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-332-30	`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	21695-332-25	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-332-30	`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	21695-332-25	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-332-30	`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	21695-332-25	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-332-30	`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	21695-332-25	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-332-30	`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	21695-332-25	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-332-30	`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
A074880-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074880-001	AN

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	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`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	A074880-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074880-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074880-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074880-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074880-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074880-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074880-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074880-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074880-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074880-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074880-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074880-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074880-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074880-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074880-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074880-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074880-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074880-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074880-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074880-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074880-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074880-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074880-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074880-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074880-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074880-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074880-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074880-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074880-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074880-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074880-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074880-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074880-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074880-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074880-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074880-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074880-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074880-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074880-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074880-001	AN	1	`cb3db0bc1861…`

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
21695-332-25	2019-09-24	C162847	48780-1	934fe258-4b2a-48b1-e053-8cdaa90a720a	Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 ml
21695-332-30	2019-09-24	C162847	48780-1	934fe258-4b2a-48b1-e053-8cdaa90a720a	Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 ml

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-332-25	Albuterol Sulfate	1 in 1 CARTON	SOLUTION	1	2
21695-332-25	Albuterol Sulfate	25 in 1 POUCH	SOLUTION	25	2
21695-332-30	Albuterol Sulfate	1 in 1 CARTON	SOLUTION	1	2
21695-332-30	Albuterol Sulfate	30 in 1 POUCH	SOLUTION	30	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-332-25	ML - Milliliter	21695-332	48de902f-eea7-43ee-ba64-113ec0df669c	1	2012-07-24
21695-332-30	ML - Milliliter	21695-332	9d0bd835-6310-4910-a70d-5af7a004b369	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALBUTEROL SULFATE	ACTIVE INGREDIENT	021SEF3731	ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]	2
ALBUTEROL	ACTIVE MOIETY	QF8SVZ843E	ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]	2
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-332	ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]	2	Legacy NDC, 4 package rows	20110914_2e439746-9808-4102-a92f-bf6c3f1e3513.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol Sulfate	ALBUTEROL SULFATE	Rising Pharma Holdings, Inc.	32377c09-da6d-331c-e063-6294a90a7a46	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880
Albuterol Sulfate	ALBUTEROL SULFATE	Sportpharm LLC	a33e20e0-3936-450d-a9d9-3ff51c6f26c5	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880
Albuterol Sulfate	ALBUTEROL SULFATE	Nephron Pharmaceuticals Corporation	574824f3-51cc-4b94-9c10-e3204d8b19f8	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880
Albuterol Sulfate	ALBUTEROL SULFATE	ASCLEMED USA INC.	8ea40065-4f59-434f-9ea1-7ef006fde66e	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880
Albuterol Sulfate	ALBUTEROL SULFATE	Asclemed USA, Inc.	056e145b-87aa-4009-a7ab-2ac0bd086eb0	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880
Albuterol Sulfate	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	813d49be-3651-6759-e053-2991aa0a6a9f	2025-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880
Albuterol Sulfate	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	749992b4-69e0-0cc8-e053-2991aa0aeb25	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880
ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	9d4ef83f-8ca0-811e-e053-2995a90a6d0d	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880
Albuterol Sulfate	ALBUTEROL SULFATE	Chartwell RX, LLC	922bf33b-4d55-4c35-9f68-72efbb17c14f	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880
Albuterol Sulfate	ALBUTEROL SULFATE	A-S Medication Solutions	8f52f15f-3fb7-4b00-a19f-8721c5ac55db	2023-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880
Albuterol Sulfate	ALBUTEROL SULFATE	Proficient Rx LP	d3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880
Albuterol Sulfate	ALBUTEROL SULFATE	Asclemed USA, Inc.	8153d82c-b5c5-4aa2-bce5-b69cf2d23f5d	2020-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880

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
630208	albuterol sulfate 0.083 % Inhalation Solution	PSN	2e439746-9808-4102-a92f-bf6c3f1e3513	2
630208	albuterol 0.83 MG/ML Inhalation Solution	SCD	2e439746-9808-4102-a92f-bf6c3f1e3513	2
630208	albuterol 0.083 % Inhalation Solution	SY	2e439746-9808-4102-a92f-bf6c3f1e3513	2
630208	albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation Solution	SY	2e439746-9808-4102-a92f-bf6c3f1e3513	2
630208	albuterol 2.5 MG per 3 ML Inhalation Solution	SY	2e439746-9808-4102-a92f-bf6c3f1e3513	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-332-25	21695033225	1 in 1 CARTON	Historical
21695-332-30	21695033230	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 ml	Rebel Distributors Corp.	2010-08-31	HUMAN PRESCRIPTION DRUG LABEL	2