ALBUTEROL SULFATE

Product NDC: 50090-5735
11-digit product format: 500905735
Labeler code: 50090
Product ID: 50090-5735_1e119641-c50c-48a6-948c-b131a95908d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: albuterol sulfate
Dosage form: INHALANT
Route: RESPIRATORY (INHALATION)
Labeler: A-S Medication Solutions
Application: ANDA209959
Marketing category: ANDA
Marketing start: 2020-04-08
Substance: ALBUTEROL SULFATE
Active strength: 90 ug/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

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
A209959-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1		2020-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209959-001	AB1

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.

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	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209959-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209959-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209959-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209959-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209959-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209959-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209959-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209959-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209959-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209959-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209959-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209959-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209959-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209959-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209959-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209959-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209959-001	AB1	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209959-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209959-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209959-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209959-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209959-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209959-001	AB1	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209959-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209959-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209959-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209959-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209959-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209959-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209959-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209959-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209959-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209959-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209959-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209959-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209959-001	AB1	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209959-001	AB1	1	`a50c72e98297…`

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	90 ug/1

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
2123111	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
7ad17b39-d2de-4108-abbf-cedd650c8edd	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
50090-5735-1	ALBUTEROL SULFATE	200 in 1 CANISTER	INHALANT	200		2
50090-5735-1	ALBUTEROL SULFATE	96 in 1 CASE	INHALANT	96		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5735-1	GM - Gram	50090-5735	0b8af2ef-2e6b-4f0f-8c3f-6404dfaee57e	1	2025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5735	ALBUTEROL SULFATE INHALANT [A-S MEDICATION SOLUTIONS]	2	Current NDC, 2 package rows	20240220_7ad17b39-d2de-4108-abbf-cedd650c8edd.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Cipla USA Inc.	c4d6d76a-14b8-411a-8019-e2c923c2c532	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209959 application number: ANDA209959
Albuterol Sulfate	ALBUTEROL SULFATE	American Health Packaging	b0a5da99-6553-4088-ae27-7fa194438340	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209959 application number: ANDA209959
Albuterol Sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	1c72fd84-7dbc-45d0-ab88-fb4221ce369f	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209959 application number: ANDA209959
ALBUTEROL SULFATE	ALBUTEROL SULFATE	A-S Medication Solutions	7ad17b39-d2de-4108-abbf-cedd650c8edd	2024-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209959 application number: ANDA209959 ndc (product): 50090-5735
ALBUTEROL SULFATE	ALBUTEROL SULFATE	A-S Medication Solutions	a9188951-3711-412c-89c6-e8db784dcb65	2023-09-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209959 application number: ANDA209959
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Exelan Pharmaceuticals, Inc.	29e35e54-dbd6-4426-993f-893d7a4d69be	2022-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209959 application number: ANDA209959

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
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	PSN	7ad17b39-d2de-4108-abbf-cedd650c8edd	2
2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	7ad17b39-d2de-4108-abbf-cedd650c8edd	2
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	SY	7ad17b39-d2de-4108-abbf-cedd650c8edd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-5735-1	50090573501	96 CANISTER in 1 CASE (50090-5735-1) / 200 INHALANT in 1 CANISTER	96 canister	2022-12-19	No	No	Current