Albuterol

Product NDC: 75834-274
11-digit product format: 758340274
Labeler code: 75834
Product ID: 75834-274_5b89a3bb-e3bb-421d-89f7-f180e01a1b4d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: albuterol sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Nivagen Pharmaceuticals Inc
Application: ANDA210948
Marketing category: ANDA
Marketing start: 2021-01-21
Substance: ALBUTEROL SULFATE
Active strength: 4 mg/1
Pharmacologic classes: Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	75834-274		D	Discontinued by firm		2026-09-14
excluded package	package	75834-274	75834-274-01	D	Discontinued by firm		2026-09-14

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210948-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL			2019-03-15
A210948-002	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL			2019-03-15

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 3 · 86 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	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL		2019-03-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL		2019-03-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL		2019-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL		2019-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	BX	2019-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	BX	2019-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	BX	2019-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	BX	2019-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	BX	2019-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	BX	2019-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	BX	2019-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	BX	2019-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	BX	2019-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	BX	2019-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	BX	2019-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	BX	2019-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	BX	2019-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	BX	2019-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	BX	2019-03-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	BX	2019-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	BX	2019-03-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	BX	2019-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	BX	2019-03-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	BX	2019-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	BX	2019-03-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	BX	2019-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	BX	2019-03-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	BX	2019-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2019-03-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2019-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2019-03-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2019-03-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2019-03-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2019-03-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2019-03-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2019-03-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2019-03-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2019-03-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210948-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2019-03-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210948-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2019-03-15	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	A210948-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210948-002	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210948-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210948-002	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210948-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210948-002	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210948-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210948-002	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210948-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210948-002	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210948-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210948-002	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210948-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210948-002	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210948-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210948-002	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210948-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210948-002	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210948-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210948-002	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210948-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210948-002	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210948-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210948-002	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210948-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210948-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210948-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210948-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210948-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210948-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210948-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210948-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210948-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210948-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210948-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210948-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210948-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210948-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210948-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210948-002	AB	1	`782e0a99824c…`

Reported adverse events (FAERS/openFDA)#

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

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
75834-274-01	2022-02-16	C162847	48780-1	d6a99b39-4c0a-a426-e053-dadaa90af4c2	albuterol-tablets
75834-274-01	2022-01-28	C162847	48780-1	d6a99b39-4c0a-a426-e053-dadaa90af4c2	albuterol-tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75834-274-01	Albuterol	100 in 1 BOTTLE, PLASTIC	TABLET	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75834-274-01	EA - Each	75834-274	6d31ebf0-42ea-4060-9cb0-d2f235712b9e	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75834-274	ALBUTEROL (ALBUTEROL SULFATE) TABLET [NIVAGEN PHARMACEUTICALS INC]	4	Current NDC, Legacy NDC, 1 package rows	20220217_b735e92d-eb1a-6fc1-e053-2995a90afce2.zip

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
197316	albuterol 2 MG Oral Tablet	PSN	b735e92d-eb1a-6fc1-e053-2995a90afce2	4
197318	albuterol 4 MG Oral Tablet	PSN	b735e92d-eb1a-6fc1-e053-2995a90afce2	4
197316	albuterol 2 MG Oral Tablet	SCD	b735e92d-eb1a-6fc1-e053-2995a90afce2	4
197318	albuterol 4 MG Oral Tablet	SCD	b735e92d-eb1a-6fc1-e053-2995a90afce2	4
197316	albuterol 2 MG (as albuterol sulfate 2.4 MG) Oral Tablet	SY	b735e92d-eb1a-6fc1-e053-2995a90afce2	4
197318	albuterol 4 MG (as albuterol sulfate 4.8 MG) Oral Tablet	SY	b735e92d-eb1a-6fc1-e053-2995a90afce2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75834-274-01	75834027401	100 TABLET in 1 BOTTLE, PLASTIC (75834-274-01)	100 tablet	2021-01-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
albuterol-tablets	Nivagen Pharmaceuticals Inc \| Aizant Drug Research Solutions Pvt Ltd	2022-02-16	HUMAN PRESCRIPTION DRUG LABEL	4