Albuterol Sulfate

Product NDC: 0781-7296
11-digit product format: 007817296
Labeler code: 0781
Product ID: 0781-7296_44ec30c6-e178-d2ed-e063-6394a90a25a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albuterol Sulfate
Dosage form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Labeler: Sandoz Inc
Application: NDA020503
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2021-03-15
Substance: ALBUTEROL SULFATE
Active strength: 108 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 42.

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
N020503-001	PROVENTIL-HFA	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020503-001	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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	1996-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	1996-08-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	1996-08-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	1996-08-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020503-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020503-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020503-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020503-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020503-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020503-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020503-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020503-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020503-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020503-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020503-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020503-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020503-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020503-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020503-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020503-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020503-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020503-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020503-001	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020503-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020503-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020503-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020503-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020503-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020503-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020503-001	BX	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020503-001	BX	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020503-001	BX	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020503-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020503-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020503-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020503-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020503-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020503-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020503-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020503-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020503-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020503-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020503-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020503-001	AB1	1	`e64feba35796…`

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	108 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
f8a2c4b7-a162-48ab-90b0-350e4da25c66	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7480e90b-004b-ebe4-2243-4f2fefdd9e78	Product name	2	20260128
0b4ec9ca-d305-43fc-88dd-7a510313efe0	Product name	1	20260105
bb209f42-a85f-4fee-9d3d-c9dded168625	Product name	1	20251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3	Product name	3	20251118
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
3f158398-73f2-4b90-47d1-5c60e8719a98	Product name	9	20250721
b5b1095b-40cd-8a9e-b111-502545045b07	Product name	4	20250325
e190029e-423b-473c-8e04-2ada59b5b711	Product name	1	20250314
26005090-31a1-441d-920b-db3101a55d53	Product name	3	20250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04b	Product name	3	20250218
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0	Product name	2	20250117
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
0a278166-c8aa-41b6-b4a5-6ac332bde76a	Product name	1	20230718
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
c76bcd0f-25eb-471e-b970-1956c95c26c5	Product name	1	20230425
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
36390b75-5438-47d3-af60-732a654e9025	Product name	2	20220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8	Product name	6	20210518
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
1b8ea3ec-88bd-98ea-c961-00ae340b5b14	Product name	2	20200220
2686d634-e712-4007-8dbf-3d37c6c4d71f	Product name	1	20181121
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42	Product name	1	20180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
3aa5a017-61e9-0c89-adef-13e7964d22f0	Product name	3	20171208
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
3becbe78-12d9-4ad2-9b4c-1e36f8d1303a	Product name	1	20170815
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
00358076-c817-430b-b924-11d717dc307c	Product name	1	20160718
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
c3c27a99-b8bc-4955-841c-26555f58ee7e	Product name	1	20150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
669af5aa-14f3-3df7-f100-5f580ffd43c1	Product name	1	20140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fb	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
8bb82a1c-d0d0-fc27-011f-172e545f0382	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0781-7296-85	Albuterol Sulfate	1 in 1 CARTON	AEROSOL, METERED	1		6
0781-7296-85	Albuterol Sulfate	200 in 1 CANISTER	AEROSOL, METERED	200		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-7296-85	GM - Gram	0781-7296	00321f4f-b4ff-4b3e-9e0c-dc8ff1174bcc	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-7296	ALBUTEROL SULFATE AEROSOL, METERED [SANDOZ INC]	5	Current NDC, Legacy NDC, 2 package rows	20241103_f8a2c4b7-a162-48ab-90b0-350e4da25c66.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	Preferred Pharmaceuticals Inc.	d6acb5a7-555a-463a-ae65-2911d6789b42	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020503 application number: NDA020503
Albuterol Sulfate	ALBUTEROL SULFATE	Sandoz Inc	f8a2c4b7-a162-48ab-90b0-350e4da25c66	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020503 application number: NDA020503 ndc (product): 0781-7296
Albuterol Sulfate	ALBUTEROL SULFATE	REMEDYREPACK INC.	32dbec5e-044a-40b6-9b88-e1396c4b4b6e	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020503 application number: NDA020503
Albuterol Sulfate	ALBUTEROL SULFATE	Proficient Rx LP	07b1ee8b-d920-49dd-9fad-cb0fe8a35e0d	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020503 application number: NDA020503

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	f8a2c4b7-a162-48ab-90b0-350e4da25c66	6
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	PSN	d6acb5a7-555a-463a-ae65-2911d6789b42	6
2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	f8a2c4b7-a162-48ab-90b0-350e4da25c66	6
2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	d6acb5a7-555a-463a-ae65-2911d6789b42	6
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	SY	f8a2c4b7-a162-48ab-90b0-350e4da25c66	6
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	SY	d6acb5a7-555a-463a-ae65-2911d6789b42	6
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	PSN	bae7a52f-504b-416e-afdd-e6853e2d5944	5
212033	aspirin 325 MG Oral Tablet	PSN	bae7a52f-504b-416e-afdd-e6853e2d5944	5
211874	BAYER Aspirin 325 MG Oral Tablet	PSN	bae7a52f-504b-416e-afdd-e6853e2d5944	5
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	bae7a52f-504b-416e-afdd-e6853e2d5944	5
1049633	diphenhydrAMINE HCl 50 MG/ML Injectable Solution	PSN	bae7a52f-504b-416e-afdd-e6853e2d5944	5
1870225	EPINEPHrine (generic for Adrenaclick) 0.15 MG in 0.15 ML Auto-Injector	PSN	bae7a52f-504b-416e-afdd-e6853e2d5944	5
1870230	EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-Injector	PSN	bae7a52f-504b-416e-afdd-e6853e2d5944	5
310519	glucose 4 GM Chewable Tablet	PSN	bae7a52f-504b-416e-afdd-e6853e2d5944	5
198039	nitroglycerin 0.4 MG Sublingual Tablet	PSN	bae7a52f-504b-416e-afdd-e6853e2d5944	5
211874	aspirin 325 MG Oral Tablet [Bayer Aspirin]	SBD	bae7a52f-504b-416e-afdd-e6853e2d5944	5
212033	aspirin 325 MG Oral Tablet	SCD	bae7a52f-504b-416e-afdd-e6853e2d5944	5
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	bae7a52f-504b-416e-afdd-e6853e2d5944	5
1049633	diphenhydramine hydrochloride 50 MG/ML Injectable Solution	SCD	bae7a52f-504b-416e-afdd-e6853e2d5944	5
310519	glucose 4000 MG Chewable Tablet	SCD	bae7a52f-504b-416e-afdd-e6853e2d5944	5
2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	bae7a52f-504b-416e-afdd-e6853e2d5944	5
1870225	NDA020800 0.15 ML epinephrine 1 MG/ML Auto-Injector	SCD	bae7a52f-504b-416e-afdd-e6853e2d5944	5
1870230	NDA020800 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	bae7a52f-504b-416e-afdd-e6853e2d5944	5
198039	nitroglycerin 0.4 MG Sublingual Tablet	SCD	bae7a52f-504b-416e-afdd-e6853e2d5944	5
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	SY	bae7a52f-504b-416e-afdd-e6853e2d5944	5
212033	ASA 325 MG Oral Tablet	SY	bae7a52f-504b-416e-afdd-e6853e2d5944	5
211874	ASA 325 MG Oral Tablet [Bayer Aspirin]	SY	bae7a52f-504b-416e-afdd-e6853e2d5944	5
211874	Bayer Aspirin 325 MG Oral Tablet	SY	bae7a52f-504b-416e-afdd-e6853e2d5944	5
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	bae7a52f-504b-416e-afdd-e6853e2d5944	5
1049633	diphenhydramine HCl 50 MG/ML Injectable Solution	SY	bae7a52f-504b-416e-afdd-e6853e2d5944	5
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	bae7a52f-504b-416e-afdd-e6853e2d5944	5
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	bae7a52f-504b-416e-afdd-e6853e2d5944	5
1870225	epinephrine (generic for Adrenaclick) 0.15 MG per 0.15 ML Auto-Injector	SY	bae7a52f-504b-416e-afdd-e6853e2d5944	5
1870230	epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-Injector	SY	bae7a52f-504b-416e-afdd-e6853e2d5944	5
310519	glucose 4 GM Chewable Tablet	SY	bae7a52f-504b-416e-afdd-e6853e2d5944	5
198039	nitroglycerin 400 MCG Sublingual Tablet	SY	bae7a52f-504b-416e-afdd-e6853e2d5944	5
198039	NTG 0.4 MG Sublingual Tablet	SY	bae7a52f-504b-416e-afdd-e6853e2d5944	5
198039	TNG 0.4 MG Sublingual Tablet	SY	bae7a52f-504b-416e-afdd-e6853e2d5944	5
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	PSN	58d78805-3e8c-4859-b2e0-e3089f925280	4
212033	aspirin 325 MG Oral Tablet	PSN	58d78805-3e8c-4859-b2e0-e3089f925280	4
211874	BAYER Aspirin 325 MG Oral Tablet	PSN	58d78805-3e8c-4859-b2e0-e3089f925280	4
1049633	diphenhydrAMINE HCl 50 MG/ML Injectable Solution	PSN	58d78805-3e8c-4859-b2e0-e3089f925280	4
1870230	EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-Injector	PSN	58d78805-3e8c-4859-b2e0-e3089f925280	4
310519	glucose 4 GM Chewable Tablet	PSN	58d78805-3e8c-4859-b2e0-e3089f925280	4
198039	nitroglycerin 0.4 MG Sublingual Tablet	PSN	58d78805-3e8c-4859-b2e0-e3089f925280	4
211874	aspirin 325 MG Oral Tablet [Bayer Aspirin]	SBD	58d78805-3e8c-4859-b2e0-e3089f925280	4
212033	aspirin 325 MG Oral Tablet	SCD	58d78805-3e8c-4859-b2e0-e3089f925280	4
1049633	diphenhydramine hydrochloride 50 MG/ML Injectable Solution	SCD	58d78805-3e8c-4859-b2e0-e3089f925280	4
310519	glucose 4000 MG Chewable Tablet	SCD	58d78805-3e8c-4859-b2e0-e3089f925280	4
2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	58d78805-3e8c-4859-b2e0-e3089f925280	4
1870230	NDA020800 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	58d78805-3e8c-4859-b2e0-e3089f925280	4
198039	nitroglycerin 0.4 MG Sublingual Tablet	SCD	58d78805-3e8c-4859-b2e0-e3089f925280	4
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	SY	58d78805-3e8c-4859-b2e0-e3089f925280	4
212033	ASA 325 MG Oral Tablet	SY	58d78805-3e8c-4859-b2e0-e3089f925280	4
211874	ASA 325 MG Oral Tablet [Bayer Aspirin]	SY	58d78805-3e8c-4859-b2e0-e3089f925280	4
211874	Bayer Aspirin 325 MG Oral Tablet	SY	58d78805-3e8c-4859-b2e0-e3089f925280	4
1049633	diphenhydramine HCl 50 MG/ML Injectable Solution	SY	58d78805-3e8c-4859-b2e0-e3089f925280	4
1870230	epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-Injector	SY	58d78805-3e8c-4859-b2e0-e3089f925280	4
310519	glucose 4 GM Chewable Tablet	SY	58d78805-3e8c-4859-b2e0-e3089f925280	4
198039	nitroglycerin 400 MCG Sublingual Tablet	SY	58d78805-3e8c-4859-b2e0-e3089f925280	4
198039	NTG 0.4 MG Sublingual Tablet	SY	58d78805-3e8c-4859-b2e0-e3089f925280	4
198039	TNG 0.4 MG Sublingual Tablet	SY	58d78805-3e8c-4859-b2e0-e3089f925280	4
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	PSN	9d434eb2-93a6-4a44-bb41-03517f8bbb68	2
2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	9d434eb2-93a6-4a44-bb41-03517f8bbb68	2
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	SY	9d434eb2-93a6-4a44-bb41-03517f8bbb68	2
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	PSN	c9ec73cb-1ba2-529b-e053-2a95a90a9eee	1
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	PSN	32dbec5e-044a-40b6-9b88-e1396c4b4b6e	1
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	PSN	07b1ee8b-d920-49dd-9fad-cb0fe8a35e0d	1
2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	c9ec73cb-1ba2-529b-e053-2a95a90a9eee	1
2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	32dbec5e-044a-40b6-9b88-e1396c4b4b6e	1
2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	07b1ee8b-d920-49dd-9fad-cb0fe8a35e0d	1
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	SY	c9ec73cb-1ba2-529b-e053-2a95a90a9eee	1
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	SY	07b1ee8b-d920-49dd-9fad-cb0fe8a35e0d	1
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	SY	32dbec5e-044a-40b6-9b88-e1396c4b4b6e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-7296-85	00781729685	1 CANISTER in 1 CARTON (0781-7296-85) / 200 AEROSOL, METERED in 1 CANISTER	1 canister	2021-03-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Albuterol Sulfate Inhalation Aerosol with Dose Indicator	Preferred Pharmaceuticals Inc.	2026-01-14	HUMAN PRESCRIPTION DRUG LABEL	6
Albuterol Sulfate Inhalation Aerosol with Dose Indicator	Sandoz Inc \| Kindeva Drug Delivery L.P. \| Kindeva Drug Delivery Limited	2025-12-16	HUMAN PRESCRIPTION DRUG LABEL	6
Albuterol Sulfate Inhalation Aerosol with Dose Indicator	REMEDYREPACK INC.	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	1
Deluxe Dental Emergency Kit	Best Dental Kit LLC	2025-10-16	HUMAN PRESCRIPTION DRUG LABEL	5
Basic Dental Emergency Kit	Best Dental Kit LLC	2025-10-16	HUMAN PRESCRIPTION DRUG LABEL	4
Albuterol Sulfate Inhalation Aerosol with Dose Indicator	Bryant Ranch Prepack	2025-08-25	HUMAN PRESCRIPTION DRUG LABEL	104
Albuterol Sulfate Inhalation Aerosol with Dose Indicator	Quality Care Products, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	3
Albuterol Sulfate Inhalation Aerosol with Dose Indicator	Proficient Rx LP	2023-10-01	HUMAN PRESCRIPTION DRUG LABEL	1
Albuterol Sulfate Inhalation Aerosol with Dose Indicator	RPK Pharmaceuticals, Inc.	2023-08-07	HUMAN PRESCRIPTION DRUG LABEL	2
Albuterol Sulfate Inhalation Aerosol with Dose Indicator	NuCare Pharmaceuticals,Inc.	2021-08-19	HUMAN PRESCRIPTION DRUG LABEL	1