Ipratropium Bromide

Product NDC: 70518-3558
11-digit product format: 705183558
Labeler code: 70518
Product ID: 70518-3558_f0e7bc44-3d4b-0ed0-e053-2a95a90af39d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ipratropium Bromide
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: REMEDYREPACK INC.
Application: ANDA075693
Marketing category: ANDA
Marketing start: 2022-10-21
Marketing end: 0000-00-00
Substance: IPRATROPIUM BROMIDE
Active strength: 1 mg/2.5mL
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	70518-3558		D	Discontinued by firm		2026-08-03
excluded package	package	70518-3558	70518-3558-0	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 · 20 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	70518-3558-0	`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	70518-3558-0	`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	70518-3558-0	`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	70518-3558-0	`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	70518-3558-0	`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	70518-3558-0	`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	70518-3558-0	`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	70518-3558-0	`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	70518-3558-0	`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	70518-3558-0	`ad56d346431e…`	`cc804d4bbf1e…`

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
A075693-001	IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075693-001	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	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`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	A075693-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075693-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075693-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075693-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075693-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075693-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075693-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075693-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075693-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075693-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075693-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075693-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075693-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075693-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075693-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075693-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075693-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075693-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075693-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075693-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075693-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075693-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075693-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075693-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075693-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075693-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075693-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075693-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075693-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075693-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075693-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075693-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075693-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075693-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075693-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075693-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075693-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075693-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075693-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075693-001	AN	1	`cb3db0bc1861…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ipratropium Bromide	IPRATROPIUM BROMIDE	Cardinal Health 107, LLC	6b730dd7-4d93-403a-bfd2-fa0efa298b75	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075693 application number: ANDA075693
Ipratropium Bromide	IPRATROPIUM BROMIDE	Cardinal Health 107, LLC	51350fab-a919-4d97-9d0c-d9dc7286244c	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075693 application number: ANDA075693
Ipratropium Bromide	IPRATROPIUM BROMIDE	Redpharm Drug	52c63e41-dbbc-d9d7-e063-6294a90a30c9	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075693 application number: ANDA075693
Ipratropium Bromide	IPRATROPIUM BROMIDE	Ritedose Pharmaceuticals, LLC	22479633-624a-4251-ad3c-1dcba5d503fb	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075693 application number: ANDA075693
Ipratropium Bromide	IPRATROPIUM BROMIDE	NuCare Pharmaceuticals, Inc.	2b9b619a-5e2a-73ef-e063-6394a90a97fe	2025-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075693 application number: ANDA075693
Ipratropium Bromide	IPRATROPIUM BROMIDE	A-S Medication Solutions	7159cf05-da58-4eb9-9e6d-a7f24eec5f46	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075693 application number: ANDA075693
Ipratropium Bromide	IPRATROPIUM BROMIDE	American Health Packaging	8927f392-4c88-4ac1-a934-c444ecf6b2c8	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075693 application number: ANDA075693
Ipratropium Bromide	IPRATROPIUM BROMIDE	A-S Medication Solutions	9f7b2f09-e831-4e15-b226-5cef3b613bd1	2023-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075693 application number: ANDA075693
Ipratropium Bromide	IPRATROPIUM BROMIDE	Mylan Pharmaceuticals Inc.	f625d3e3-c175-4d9a-99ea-dab410b262f1	2013-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075693 application number: ANDA075693

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
70518-3558-0	70518355800	2 POUCH in 1 CARTON (70518-3558-0) > 30 AMPULE in 1 POUCH > 2.5 mL in 1 AMPULE	2 pouch	2022-10-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ipratropium Bromide Inhalation Solution 0.02%	REMEDYREPACK INC.	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL	3