Ipratropium Bromide

Product NDC: 53217-008
11-digit product format: 532170008
Labeler code: 53217
Product ID: 53217-008_3a79526b-bcfe-4635-82a6-73cafe9b13eb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ipratropium Bromide
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA075693
Marketing category: ANDA
Marketing start: 2011-02-01
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: 2019-12-31
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	53217-008		I	Inactivated by FDA		2026-08-17
excluded package	package	53217-008	53217-008-01	I	Inactivated by FDA		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 · 42 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	53217-008-01	`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	53217-008-01	`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	53217-008-01	`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	53217-008-01	`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	53217-008-01	`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	53217-008-01	`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	53217-008-01	`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	53217-008-01	`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	53217-008-01	`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	53217-008-01	`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	53217-008-01	`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	53217-008-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53217-008-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53217-008-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53217-008-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53217-008-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53217-008-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53217-008-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53217-008-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53217-008-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53217-008-01	`9bebd1f3094a…`	`5416666fcb17…`

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
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 · 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	A075693-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	RS	2001-01-26	`caaa826d4ba7…`
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…`

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	A075693-001	AN	1	`caaa826d4ba7…`
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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9ccc399f-9de9-4e86-a0ca-d7a2e7c6c36c	Product name	2	20251106
d953267a-4ca0-4d44-91ad-712cdee8ab38	Product name	2	20250630
0a278166-c8aa-41b6-b4a5-6ac332bde76a	Product name	1	20230718
6ac73021-459f-435b-b6c5-8c7d6a50c021	Product name	2	20170404

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-008-01	2020-01-31	C162847	48780-1	9d75b9d0-fa9f-f424-e053-dadaa90a57ce	IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-008-01	Ipratropium Bromide	30 in 1 POUCH	SOLUTION	30		1
53217-008-01	Ipratropium Bromide	2 in 1 CARTON	SOLUTION	2		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53217-008-01	ML - Milliliter	53217-008	de44b5ea-c4fa-4aa7-bac5-24a15dacc244	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IPRATROPIUM BROMIDE	ACTIVE INGREDIENT	J697UZ2A9J	IPRATROPIUM BROMIDE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1
IPRATROPIUM	ACTIVE MOIETY	GR88G0I6UL	IPRATROPIUM BROMIDE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	IPRATROPIUM BROMIDE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	IPRATROPIUM BROMIDE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	IPRATROPIUM BROMIDE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-008	IPRATROPIUM BROMIDE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 2 package rows	20140214_769febba-671d-476b-b0c8-71489a2f9d20.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
836358	ipratropium bromide 0.02 % Inhalation Solution	PSN	769febba-671d-476b-b0c8-71489a2f9d20	1
836358	ipratropium bromide 0.2 MG/ML Inhalation Solution	SCD	769febba-671d-476b-b0c8-71489a2f9d20	1
836358	ipratropium bromide 0.02 % Inhalation Solution	SY	769febba-671d-476b-b0c8-71489a2f9d20	1
836358	ipratropium bromide 0.5 MG per 2.5 ML Inhalation Solution	SY	769febba-671d-476b-b0c8-71489a2f9d20	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-008-01	53217000801	30 in 1 POUCH	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02%	Aidarex Pharmaceuticals LLC	2013-10-06	HUMAN PRESCRIPTION DRUG LABEL	1