Albuterol Sulfate

Product NDC: 65302-045
11-digit product format: 653020045
Labeler code: 65302
Product ID: 65302-045_9adaf3f5-104b-264f-e053-2a95a90ad788
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albuterol Sulfate
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: The Ritedose Corporation
Application: ANDA077839
Marketing category: ANDA
Marketing start: 2018-12-26
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: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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
A077839-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN		2008-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077839-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`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	A077839-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077839-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077839-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077839-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077839-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077839-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077839-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077839-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077839-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077839-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077839-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077839-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077839-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077839-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077839-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077839-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077839-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077839-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077839-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077839-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077839-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077839-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077839-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077839-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077839-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077839-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077839-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077839-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077839-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077839-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077839-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077839-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077839-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077839-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077839-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077839-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077839-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077839-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077839-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077839-001	AN	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol Sulfate	ALBUTEROL SULFATE	American Health Packaging	4aec7f59-b429-4b0e-a779-8df1dd8f80d7	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	Ritedose Pharmaceuticals, LLC	b72742df-1a6b-4483-aff3-3e79db5e015d	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	Cardinal Health 107, LLC	d2132c1c-0f90-4c6f-afc0-f3814b6a7e5c	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	Cardinal Health 107, LLC	6ec88f64-66a2-4ca9-9913-c192fc33f88b	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	c90e80b2-882e-4c0c-bfac-d67eb1da724d	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	Mylan Pharmaceuticals Inc.	5329614f-ae0b-4854-bb6f-ea0b7dae87c0	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	NuCare Pharmaceuticals, Inc.	2c3f975c-dbd8-0362-e063-6394a90a16dd	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	A-S Medication Solutions	19867b61-77a2-46f1-97c7-7fadfec5882b	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	Medical Purchasing Solutions, LLC	6a4b4b95-d1d3-9051-e053-2a91aa0a52e8	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839

Albuterol Sulfate

Orange Book products#

Therapeutic equivalence codes#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#