Albuterol Sulfate

Product NDC: 68071-3780
11-digit product format: 680713780
Labeler code: 68071
Product ID: 68071-3780_41afaa31-2e58-8cd4-e063-6294a90af56c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albuterol Sulfate
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA077839
Marketing category: ANDA
Marketing start: 2011-12-05
Substance: ALBUTEROL SULFATE
Active strength: 2.5 mg/3mL
Pharmacologic classes: Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Albuterol Sulfate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALBUTEROL SULFATE	2.5 mg/3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
021SEF3731	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
630208	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2c3f975c-dbd8-0362-e063-6394a90a16dd	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3780-2	Albuterol Sulfate	25 in 1 POUCH	SOLUTION	25		3
68071-3780-2	Albuterol Sulfate	1 in 1 CARTON	SOLUTION	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3780	ALBUTEROL SULFATE SOLUTION [NUCARE PHARMACEUTICALS, INC.]	1	Current NDC, 2 package rows	20250123_2c3f975c-dbd8-0362-e063-6394a90a16dd.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 ndc (product): 68071-3780
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
630208	albuterol sulfate 0.083 % Inhalation Solution	PSN	2c3f975c-dbd8-0362-e063-6394a90a16dd	3
630208	albuterol 0.83 MG/ML Inhalation Solution	SCD	2c3f975c-dbd8-0362-e063-6394a90a16dd	3
630208	albuterol 0.083 % Inhalation Solution	SY	2c3f975c-dbd8-0362-e063-6394a90a16dd	3
630208	albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation Solution	SY	2c3f975c-dbd8-0362-e063-6394a90a16dd	3
630208	albuterol 2.5 MG per 3 ML Inhalation Solution	SY	2c3f975c-dbd8-0362-e063-6394a90a16dd	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3780-2	68071378002	1 POUCH in 1 CARTON (68071-3780-2) / 25 AMPULE in 1 POUCH / 3 mL in 1 AMPULE	1 pouch	2025-01-21	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)	NuCare Pharmaceuticals, Inc.	2025-10-21	HUMAN PRESCRIPTION DRUG LABEL	3