Ipratropium Bromide

Product NDC: 50090-4185
Requested package NDC: 50090-4185-0
11-digit product format: 500904185
Labeler code: 50090
Product ID: 50090-4185_0e262d16-2912-49fb-b7ed-50b2346b08b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ipratropium Bromide
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: A-S Medication Solutions
Application: ANDA075562
Marketing category: ANDA
Marketing start: 2001-09-27
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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-4185	50090-4185-0	I	Inactivated by FDA		2026-09-14

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A075562-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2001-09-27	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075562-001	AN	1	`84e616aacf4f…`
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…`

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
50090-4185-0	2023-01-30	C162847	48780-1	f386c64a-371d-0266-e053-dadaa90a7c1a	Ipratropium Bromide Inhalation Solution, 0.02% FOR INHALATION USE ONLY – NOT FOR INJECTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4185-0	Ipratropium Bromide	1 in 1 CARTON	SOLUTION	1		2
50090-4185-0	Ipratropium Bromide	25 mL in 1 POUCH	SOLUTION	25		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4185	IPRATROPIUM BROMIDE SOLUTION [A-S MEDICATION SOLUTIONS]	2	Legacy NDC, 2 package rows	20190601_9eb6a1c2-1e95-4926-a684-b53b8bc95ebd.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
836358	ipratropium bromide 0.02 % Inhalation Solution	PSN	9eb6a1c2-1e95-4926-a684-b53b8bc95ebd	2
836358	ipratropium bromide 0.2 MG/ML Inhalation Solution	SCD	9eb6a1c2-1e95-4926-a684-b53b8bc95ebd	2
836358	ipratropium bromide 0.02 % Inhalation Solution	SY	9eb6a1c2-1e95-4926-a684-b53b8bc95ebd	2
836358	ipratropium bromide 0.5 MG per 2.5 ML Inhalation Solution	SY	9eb6a1c2-1e95-4926-a684-b53b8bc95ebd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4185-0	50090418500	1 POUCH in 1 CARTON (50090-4185-0) > 25 mL in 1 POUCH	1 pouch	2019-03-14	0000-00-00	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	A-S Medication Solutions	2019-05-31	HUMAN PRESCRIPTION DRUG LABEL	2