Albuterol Sulfate

Product NDC: 67296-2338
11-digit product format: 672962338
Labeler code: 67296
Product ID: 67296-2338_5d6296ac-3e02-6bba-e063-6394a90af45b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: albuterol sulfate
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Redpharm Drug
Application: ANDA207857
Marketing category: ANDA
Marketing start: 2021-06-11
Substance: ALBUTEROL SULFATE
Active strength: .83 mg/mL
Pharmacologic classes: Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207857-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN		2017-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207857-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207857-001	AN	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207857-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207857-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207857-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207857-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207857-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207857-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207857-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207857-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207857-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207857-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207857-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207857-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207857-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207857-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207857-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207857-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207857-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207857-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207857-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207857-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207857-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207857-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207857-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207857-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207857-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207857-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207857-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207857-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207857-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207857-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207857-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207857-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207857-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207857-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207857-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207857-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207857-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207857-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207857-001	AN	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	REMEDYREPACK INC.	0f9bf2c8-55c0-4b4d-97de-d6c7220c3862	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207857 application number: ANDA207857
Albuterol Sulfate	ALBUTEROL SULFATE	Sun Pharmaceutical Industries, Inc.	bb538b7d-e390-419a-9404-a57c1db4a447	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207857 application number: ANDA207857
Albuterol Sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	5de6a189-a8b7-4b33-b162-add6b6e4b275	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207857 application number: ANDA207857
Albuterol Sulfate	ALBUTEROL SULFATE	Proficient Rx LP	a6545fbe-b0a6-41ae-8bb6-91af38410f56	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207857 application number: ANDA207857

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
021SEF3731	ALBUTEROL SULFATE	51022-70-9	ALBUTEROL SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2338-9	67296233809	6 POUCH in 1 CARTON (67296-2338-9) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL	6 pouch	2021-06-11	No	No	Historical