Albuterol Sulfate

Product NDC: 70518-3442
Requested package NDC: 70518-3442-0
11-digit product format: 705183442
Labeler code: 70518
Product ID: 70518-3442_e531328f-9ffc-08ed-e053-2995a90a5693
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albuterol Sulfate
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: REMEDYREPACK INC.
Application: ANDA077839
Marketing category: ANDA
Marketing start: 2022-06-23
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3442	70518-3442-0	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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70518-3442	70518-3442-0	I	Inactivated by FDA		excluded / ndc_excluded.zip	`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
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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3442-0	2024-03-20	C162847	48780-1	1030e365-04fa-111a-e063-dadaa90a10e2	Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL (RDP)
70518-3442-0	2024-01-30	C162847	48780-1	1030e365-04fa-111a-e063-dadaa90a10e2	Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL (RDP)

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3442	ALBUTEROL SULFATE SOLUTION [REMEDYREPACK INC.]	3	Legacy NDC	20240709_aa3a49f3-667a-4897-a1b7-f067d025a93c.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 · 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

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
70518-3442-0	70518344200	1 POUCH in 1 CARTON (70518-3442-0) > 25 AMPULE in 1 POUCH > 3 mL in 1 AMPULE	1 pouch	2022-06-23	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 (RDP)	REMEDYREPACK INC.	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	4