Albuterol Sulfate

Product NDC: 68071-2679
Requested package NDC: 68071-2679-6
11-digit product format: 680712679
Labeler code: 68071
Product ID: 68071-2679_ddbb0c0d-9090-af1d-e053-2995a90afde0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: albuterol sulfate
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA207857
Marketing category: ANDA
Marketing start: 2021-06-11
Marketing end: 0000-00-00
Substance: ALBUTEROL SULFATE
Active strength: 1 mg/mL
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	68071-2679	68071-2679-6	I	Inactivated by FDA		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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207857-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2017-07-21	`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	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…`
2022-09-29 23:25 UTC	2022-09	A207857-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207857-001	AN	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2679-6	2025-01-30	C162847	48780-1	2cef2736-a70f-d83d-e063-dadaa90ab31f	Albuterol Sulfate Inhalation Solution 0.083%* (*Potency expressed as albuterol) PRESCRIBING INFORMATION FOR INHALATION USE ONLY–NOT FOR INJECTION.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2679-6	Albuterol Sulfate	6 in 1 CARTON	SOLUTION	6		1
68071-2679-6	Albuterol Sulfate	3 mL in 1 VIAL	SOLUTION	3		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2679	ALBUTEROL SULFATE SOLUTION [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 2 package rows	20220429_ddbb0c14-b27f-4be9-e053-2a95a90afc04.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
630208	albuterol sulfate 0.083 % Inhalation Solution	PSN	ddbb0c14-b27f-4be9-e053-2a95a90afc04	1
630208	albuterol 0.83 MG/ML Inhalation Solution	SCD	ddbb0c14-b27f-4be9-e053-2a95a90afc04	1
630208	albuterol 0.083 % Inhalation Solution	SY	ddbb0c14-b27f-4be9-e053-2a95a90afc04	1
630208	albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation Solution	SY	ddbb0c14-b27f-4be9-e053-2a95a90afc04	1
630208	albuterol 2.5 MG per 3 ML Inhalation Solution	SY	ddbb0c14-b27f-4be9-e053-2a95a90afc04	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2679-6	68071267906	6 VIAL in 1 CARTON (68071-2679-6) > 3 mL in 1 VIAL	6 vial	2022-04-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Albuterol Sulfate - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2022-04-28	HUMAN PRESCRIPTION DRUG LABEL	1