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 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
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.

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
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020503-001	AB1	1	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	N020503-001	AB1	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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