albuterol sulfate

Product NDC: 68084-952
Requested package NDC: 68084-952-25
11-digit product format: 680840952
Labeler code: 68084
Product ID: 68084-952_ea3ce764-6a19-559c-e053-2a95a90add3c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: albuterol sulfate
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA072637
Marketing category: ANDA
Marketing start: 2015-09-16
Marketing end: 0000-00-00
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: 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	68084-952	68084-952-25	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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A072637-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB		1989-12-05
A072637-002	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1989-12-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A072637-001	AB
A072637-002	AB

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 · 82 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	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A072637-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072637-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072637-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072637-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072637-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072637-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072637-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072637-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072637-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072637-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072637-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072637-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072637-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072637-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072637-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072637-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072637-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072637-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072637-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072637-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072637-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072637-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072637-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072637-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072637-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072637-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072637-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A072637-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072637-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072637-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072637-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A072637-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072637-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A072637-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072637-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A072637-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072637-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A072637-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072637-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A072637-002	AB	1	`782e0a99824c…`

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
68084-952-25	Albuterol Sulfate	30 in 1 BOX, UNIT-DOSE	TABLET	30		5
68084-952-95	Albuterol Sulfate	1 in 1 BLISTER PACK	TABLET	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-952-25	EA - Each	68084-952	10932747-c4cb-4e52-981f-44aee28ec466	1	2015-11-12
68084-952-95	EA - Each	68084-952	74e13657-2856-4a7c-a03d-05342393dbb1	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
albuterol sulfate	ACTIVE INGREDIENT	021SEF3731	ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]	1
albuterol	ACTIVE MOIETY	QF8SVZ843E	ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]	1
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]	1
sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-952	ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]	5	Legacy NDC, 2 package rows	20240731_b0f73459-baeb-42a7-be48-2c3647d9b205.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
albuterol sulfate	ALBUTEROL SULFATE	Golden State Medical Supply, Inc.	a22af54a-c010-ab8b-e053-2a95a90a8862	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072637 application number: ANDA072637
albuterol sulfate	ALBUTEROL SULFATE	Sun Pharmaceutical Industries, Inc.	87b8cd3c-2849-4b50-b63e-9ea379165c07	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072637 application number: ANDA072637
Albuterol Sulfate	ALBUTEROL SULFATE	American Health Packaging	b0f73459-baeb-42a7-be48-2c3647d9b205	2024-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072637 application number: ANDA072637 ndc (package): 68084-952-25 ndc (product): 68084-952 ndc11 (package): 68084095225

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	b0f73459-baeb-42a7-be48-2c3647d9b205	5
197318	albuterol 4 MG Oral Tablet	PSN	b0f73459-baeb-42a7-be48-2c3647d9b205	5
197316	albuterol 2 MG Oral Tablet	SCD	b0f73459-baeb-42a7-be48-2c3647d9b205	5
197318	albuterol 4 MG Oral Tablet	SCD	b0f73459-baeb-42a7-be48-2c3647d9b205	5
197316	albuterol 2 MG (as albuterol sulfate 2.4 MG) Oral Tablet	SY	b0f73459-baeb-42a7-be48-2c3647d9b205	5
197318	albuterol 4 MG (as albuterol sulfate 4.8 MG) Oral Tablet	SY	b0f73459-baeb-42a7-be48-2c3647d9b205	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-952-25	68084095225	30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-952-25) > 1 TABLET in 1 BLISTER PACK (68084-952-95)	30 blister pack	2015-09-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Albuterol Tablets USP Rx only 8294921/0624F	American Health Packaging	2024-07-30	HUMAN PRESCRIPTION DRUG LABEL	5