Ipratropium Bromide

Product NDC: 63187-188
Requested package NDC: 63187-188-25
11-digit product format: 631870188
Labeler code: 63187
Product ID: 63187-188_c9fb97e3-6748-4b7f-a562-6e4950ec3e4f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ipratropium Bromide
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Proficient Rx LP
Application: ANDA075693
Marketing category: ANDA
Marketing start: 2011-03-01
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: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	63187-188	63187-188-25	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 2 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-188	63187-188-25	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-188	63187-188-25	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IPRATROPIUM BROMIDE	ACTIVE INGREDIENT	J697UZ2A9J	IPRATROPIUM BROMIDE SOLUTION [PROFICIENT RX LP]	1
IPRATROPIUM	ACTIVE MOIETY	GR88G0I6UL	IPRATROPIUM BROMIDE SOLUTION [PROFICIENT RX LP]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	IPRATROPIUM BROMIDE SOLUTION [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	IPRATROPIUM BROMIDE SOLUTION [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-188	IPRATROPIUM BROMIDE SOLUTION [PROFICIENT RX LP]	3	Legacy NDC	20200131_32d09bd1-f31d-4f39-9600-f80b4eff02f1.zip

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
63187-188-25	63187018825	1 POUCH in 1 CARTON (63187-188-25) > 25 VIAL in 1 POUCH > 2.5 mL in 1 VIAL	1 pouch	2019-01-01	0000-00-00	No	No	Current