FDA.reportPublic FDA data

Ipratropium Bromide

Product NDC
0591-3798
11-digit product format
005913798
Labeler code
0591
Product ID
0591-3798_cdc5d8b0-a363-4896-996c-10a592370db9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Actavis Pharma, Inc.
Application
ANDA075693
Marketing category
ANDA
Marketing start
2011-03-01
Marketing end
2022-04-30
Substance
IPRATROPIUM BROMIDE
Active strength
1 mg/2.5mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0591-3798DDiscontinued by firm2026-07-31
excluded packagepackage0591-37980591-3798-30DDiscontinued by firm2026-07-31
excluded packagepackage0591-37980591-3798-60DDiscontinued by firm2026-07-31
excluded packagepackage0591-37980591-3798-83DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075693-001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075693-001AN

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075693-001AN1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ipratropium BromideIPRATROPIUM BROMIDECardinal Health 107, LLC6b730dd7-4d93-403a-bfd2-fa0efa298b752026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDECardinal Health 107, LLC51350fab-a919-4d97-9d0c-d9dc7286244c2026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDERedpharm Drug52c63e41-dbbc-d9d7-e063-6294a90a30c92026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDERitedose Pharmaceuticals, LLC22479633-624a-4251-ad3c-1dcba5d503fb2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDENuCare Pharmaceuticals, Inc.2b9b619a-5e2a-73ef-e063-6394a90a97fe2025-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDEA-S Medication Solutions7159cf05-da58-4eb9-9e6d-a7f24eec5f462025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDEAmerican Health Packaging8927f392-4c88-4ac1-a934-c444ecf6b2c82024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDEA-S Medication Solutions9f7b2f09-e831-4e15-b226-5cef3b613bd12023-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDEMylan Pharmaceuticals Inc.f625d3e3-c175-4d9a-99ea-dab410b262f12013-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9ccc399f-9de9-4e86-a0ca-d7a2e7c6c36cProduct name220251106
d953267a-4ca0-4d44-91ad-712cdee8ab38Product name220250630
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
6ac73021-459f-435b-b6c5-8c7d6a50c021Product name220170404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3798-30ML - Milliliter0591-37980ce7c849-95b4-443a-a0c7-de5fb378c69712012-07-24
0591-3798-60ML - Milliliter0591-3798c0af4c9a-57a0-4a4d-9cd6-aa7d19cf4e8712012-07-24
0591-3798-83ML - Milliliter0591-3798ba98e452-fc74-442f-b42a-2a3efc95f20712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IPRATROPIUM BROMIDEACTIVE INGREDIENTJ697UZ2A9JIPRATROPIUM BROMIDE SOLUTION [WATSON LABORATORIES, INC.]5
IPRATROPIUMACTIVE MOIETYGR88G0I6ULIPRATROPIUM BROMIDE SOLUTION [WATSON LABORATORIES, INC.]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBIPRATROPIUM BROMIDE SOLUTION [WATSON LABORATORIES, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RIPRATROPIUM BROMIDE SOLUTION [WATSON LABORATORIES, INC.]5
IPRATROPIUM BROMIDEACTIVE INGREDIENTJ697UZ2A9JIPRATROPIUM BROMIDE SOLUTION [PROFICIENT RX LP]1
IPRATROPIUM BROMIDEACTIVE INGREDIENTJ697UZ2A9JIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
IPRATROPIUMACTIVE MOIETYGR88G0I6ULIPRATROPIUM BROMIDE SOLUTION [PROFICIENT RX LP]1
IPRATROPIUMACTIVE MOIETYGR88G0I6ULIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBIPRATROPIUM BROMIDE SOLUTION [PROFICIENT RX LP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RIPRATROPIUM BROMIDE SOLUTION [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836358ipratropium bromide 0.02 % Inhalation SolutionPSN95990ec1-9cfd-4b94-afbd-7ced6ecca5671
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD95990ec1-9cfd-4b94-afbd-7ced6ecca5671
836358ipratropium bromide 0.02 % Inhalation SolutionSY95990ec1-9cfd-4b94-afbd-7ced6ecca5671
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY95990ec1-9cfd-4b94-afbd-7ced6ecca5671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-3798-30005913798301 POUCH in 1 CARTON (0591-3798-30) > 30 VIAL in 1 POUCH > 2.5 mL in 1 VIAL1 pouch2011-03-010000-00-00NoNoCurrent
0591-3798-60005913798602 POUCH in 1 CARTON (0591-3798-60) > 30 VIAL in 1 POUCH > 2.5 mL in 1 VIAL2 pouch2011-03-010000-00-00NoNoCurrent
0591-3798-83005913798831 POUCH in 1 CARTON (0591-3798-83) > 25 VIAL in 1 POUCH > 2.5 mL in 1 VIAL1 pouch2011-03-010000-00-00NoNoCurrent