Albuterol Sulfate

Product NDC: 68071-4048
11-digit product format: 680714048
Labeler code: 68071
Product ID: 68071-4048_bb2be7fa-62f8-7e42-e053-2a95a90a9042
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albuterol Sulfate
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: NuCare Pharmaceuticals,Inc.
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: No
Listing certified through: 2022-12-31
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	68071-4048		D	Discontinued by firm		2026-08-03
excluded package	package	68071-4048	68071-4048-2	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 1 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-4048-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-4048-2	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-4048-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-4048-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-4048-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-4048-2	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-4048-2	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-4048-2	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-4048-2	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-4048-2	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-4048-2	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-4048-2	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-4048-2	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-4048-2	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-4048-2	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-07-17	Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 ml
2023-01-30	Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 ml
2021-02-12	Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 ml
2021-01-29	Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 ml

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4048-2	68071404802	3 mL in 1 BOX (68071-4048-2)	3 ml	2017-12-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 ml	NuCare Pharmaceuticals,Inc.	2021-02-12	HUMAN PRESCRIPTION DRUG LABEL	3