Ipratropium Bromide

Product NDC: 50090-0668
11-digit product format: 500900668
Labeler code: 50090
Product ID: 50090-0668_48b0ebf7-0563-4c63-8708-87c732ef1562
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ipratropium Bromide
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: A-S Medication Solutions
Application: ANDA075693
Marketing category: ANDA
Marketing start: 2011-02-01
Substance: IPRATROPIUM BROMIDE
Active strength: .5 mg/2.5mL
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ipratropium Bromide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IPRATROPIUM BROMIDE	.5 mg/2.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
J697UZ2A9J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
836358	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7159cf05-da58-4eb9-9e6d-a7f24eec5f46	Available on FDA.report

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
50090-0668-0	2023-02-07	C162847	48780-1	f386c64a-46fd-0266-e053-dadaa90a7c1a	Ipratropium Bromide Inhalation Solution 0.02%
50090-0668-0	2023-01-30	C162847	48780-1	f386c64a-46fd-0266-e053-dadaa90a7c1a	Ipratropium Bromide Inhalation Solution 0.02%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-0668-0	Ipratropium Bromide	1 in 1 CARTON	SOLUTION	1		10
50090-0668-0	Ipratropium Bromide	25 mL in 1 POUCH	SOLUTION	25		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0668-0	ML - Milliliter	50090-0668	f0fd9ba0-a8ce-4340-823c-300bbd40becd	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0668	IPRATROPIUM BROMIDE SOLUTION [A-S MEDICATION SOLUTIONS]	10	Current NDC, Legacy NDC, 2 package rows	20250110_7159cf05-da58-4eb9-9e6d-a7f24eec5f46.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 ndc (product): 50090-0668
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	7159cf05-da58-4eb9-9e6d-a7f24eec5f46	10
836358	ipratropium bromide 0.2 MG/ML Inhalation Solution	SCD	7159cf05-da58-4eb9-9e6d-a7f24eec5f46	10
836358	ipratropium bromide 0.02 % Inhalation Solution	SY	7159cf05-da58-4eb9-9e6d-a7f24eec5f46	10
836358	ipratropium bromide 0.5 MG per 2.5 ML Inhalation Solution	SY	7159cf05-da58-4eb9-9e6d-a7f24eec5f46	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0668-0	50090066800	1 POUCH in 1 CARTON (50090-0668-0) / 25 mL in 1 POUCH	1 pouch	2014-11-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ipratropium Bromide Inhalation Solution 0.02%	A-S Medication Solutions	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	10