Ipratropium Bromide

Product NDC: 55154-4351
11-digit product format: 551544351
Labeler code: 55154
Product ID: 55154-4351_9336d2fe-7a40-4cdd-a297-da5ab626018c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ipratropium Bromide
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Cardinal Health 107, LLC
Application: ANDA075562
Marketing category: ANDA
Marketing start: 2001-09-27
Marketing end: 2024-02-29
Substance: IPRATROPIUM BROMIDE
Active strength: 1 mg/2.5mL
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	55154-4351		D	Discontinued by firm		2026-08-17
excluded package	package	55154-4351	55154-4351-5	D	Discontinued by firm		2026-08-17

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	55154-4351-5	`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	55154-4351-5	`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	55154-4351-5	`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	55154-4351-5	`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	55154-4351-5	`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	55154-4351-5	`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	55154-4351-5	`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	55154-4351-5	`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	55154-4351-5	`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	55154-4351-5	`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	55154-4351-5	`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	55154-4351-5	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A075562-001	IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN		2001-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075562-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`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	A075562-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075562-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075562-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075562-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075562-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075562-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075562-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075562-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075562-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075562-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075562-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075562-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075562-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075562-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075562-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075562-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075562-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075562-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075562-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075562-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075562-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075562-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075562-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075562-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075562-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075562-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075562-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075562-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075562-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075562-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075562-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075562-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075562-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075562-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075562-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075562-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075562-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075562-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075562-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075562-001	AN	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55154-4351-5	ML - Milliliter	55154-4351	cd220a71-7051-4020-9392-2be38379f3ed	1	2018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IPRATROPIUM BROMIDE	ACTIVE INGREDIENT	J697UZ2A9J	IPRATROPIUM BROMIDE SOLUTION [CARDINAL HEALTH]	2
IPRATROPIUM	ACTIVE MOIETY	GR88G0I6UL	IPRATROPIUM BROMIDE SOLUTION [CARDINAL HEALTH]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	IPRATROPIUM BROMIDE SOLUTION [CARDINAL HEALTH]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	IPRATROPIUM BROMIDE SOLUTION [CARDINAL HEALTH]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	IPRATROPIUM BROMIDE SOLUTION [CARDINAL HEALTH]	2

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
Ipratropium Bromide	IPRATROPIUM BROMIDE	Rising Pharma Holdings, Inc.	3249aea8-a395-f09f-e063-6294a90a2d8b	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075562 application number: ANDA075562
Ipratropium Bromide	IPRATROPIUM BROMIDE	Chartwell RX, LLC	1e3d4faa-cf6e-460b-b1e0-fcc8094505fa	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075562 application number: ANDA075562
Ipratropium Bromide	IPRATROPIUM BROMIDE	Nephron Pharmaceuticals Corporation	db8095db-d1fd-4099-9fb1-d1ad4e284976	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075562 application number: ANDA075562

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J697UZ2A9J	IPRATROPIUM BROMIDE	66985-17-9	IPRATROPIUM BROMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-4351-5	55154435105	5 POUCH in 1 BAG (55154-4351-5) > 1 VIAL, SINGLE-DOSE in 1 POUCH > 2.5 mL in 1 VIAL, SINGLE-DOSE	5 pouch	2001-09-27	2024-02-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ipratropium Bromide Inhalation Solution, 0.02% FOR INHALATION USE ONLY – NOT FOR INJECTION	Cardinal Health 107, LLC	2022-12-27	HUMAN PRESCRIPTION DRUG LABEL	7