Ipratropium Bromide and Albuterol Sulfate

Product NDC: 55154-4357
11-digit product format: 551544357
Labeler code: 55154
Product ID: 55154-4357_170e0a42-2b47-4bd1-a8d2-ca6152a6fb6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ipratropium Bromide and Albuterol Sulfate
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Cardinal Health
Application: ANDA076749
Marketing category: ANDA
Marketing start: 2007-12-31
Marketing end: 0000-00-00
Substance: IPRATROPIUM BROMIDE; ALBUTEROL SULFATE
Active strength: 1 mg/3mL; mg/3mL
Pharmacologic classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55154-4357		D	Discontinued by firm		2026-08-03
excluded package	package	55154-4357	55154-4357-5	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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-4357-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55154-4357-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55154-4357-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55154-4357-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55154-4357-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55154-4357-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55154-4357-5	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55154-4357-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55154-4357-5	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55154-4357-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55154-4357-5	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55154-4357-5	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076749-001	AN

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A076749-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076749-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076749-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076749-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076749-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076749-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076749-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076749-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076749-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076749-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076749-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076749-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076749-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076749-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076749-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076749-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076749-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076749-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076749-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076749-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076749-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076749-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076749-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076749-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076749-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076749-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076749-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076749-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076749-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076749-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076749-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076749-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076749-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076749-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076749-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076749-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076749-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076749-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076749-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076749-001	AN	1	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALBUTEROL SULFATE	ACTIVE INGREDIENT	021SEF3731	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [CARDINAL HEALTH]	6
IPRATROPIUM BROMIDE	ACTIVE INGREDIENT	J697UZ2A9J	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [CARDINAL HEALTH]	6
ALBUTEROL	ACTIVE MOIETY	QF8SVZ843E	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [CARDINAL HEALTH]	6
IPRATROPIUM	ACTIVE MOIETY	GR88G0I6UL	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [CARDINAL HEALTH]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [CARDINAL HEALTH]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [CARDINAL HEALTH]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [CARDINAL HEALTH]	6

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
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Rising Pharma Holdings, Inc.	3246dfab-61d7-27ba-e063-6294a90ac180	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	A-S Medication Solutions	65504330-6c02-4e30-9f32-51393e06f20c	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	66f32a06-c880-4b5b-837b-951e1e01e040	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Chartwell RX, LLC	b444478a-10ce-484f-9039-6383dfb8161e	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Nephron Pharmaceuticals Corporation	ae35ec1f-526a-49bf-8262-c50e40190d1f	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Proficient Rx LP	a1d9d346-91a5-4f5a-82ed-4ebeaf350a06	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J697UZ2A9J	IPRATROPIUM BROMIDE	66985-17-9	IPRATROPIUM BROMIDE
021SEF3731	ALBUTEROL SULFATE	51022-70-9	ALBUTEROL SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-4357-5	55154435705	5 POUCH in 1 BAG (55154-4357-5) > 1 VIAL, SINGLE-USE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-USE	5 pouch	2007-12-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg* Inhalation Solution	Cardinal Health 107, LLC	2023-01-18	HUMAN PRESCRIPTION DRUG LABEL	10