FDA.reportPublic FDA data

Ipratropium Bromide

Product NDC
0781-7157
11-digit product format
007817157
Labeler code
0781
Product ID
0781-7157_a76b5f61-64c0-4a1c-85a4-a7f743fb3250
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Sandoz Inc.
Application
ANDA075693
Marketing category
ANDA
Marketing start
2011-09-01
Marketing end
0000-00-00
Substance
IPRATROPIUM BROMIDE
Active strength
1 mg/2.5mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-7157IInactivated by FDA2026-07-31
excluded packagepackage0781-71570781-7157-29IInactivated by FDA2026-07-31
excluded packagepackage0781-71570781-7157-64IInactivated by FDA2026-07-31
excluded packagepackage0781-71570781-7157-86IInactivated by FDA2026-07-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-7157-292020-01-31C16284748780-19d75b9cf-d8c2-f424-e053-dadaa90a57ceIpratropium Bromide Inhalation Solution, 0.02%
0781-7157-642020-01-31C16284748780-19d75b9cf-d8c2-f424-e053-dadaa90a57ceIpratropium Bromide Inhalation Solution, 0.02%
0781-7157-862020-01-31C16284748780-19d75b9cf-d8c2-f424-e053-dadaa90a57ceIpratropium Bromide Inhalation Solution, 0.02%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-7157-29Ipratropium Bromide30 in 1 POUCHSOLUTION303
0781-7157-29Ipratropium Bromide2 in 1 CARTONSOLUTION23
0781-7157-64Ipratropium Bromide1 in 1 CARTONSOLUTION13
0781-7157-64Ipratropium Bromide30 in 1 POUCHSOLUTION303
0781-7157-86Ipratropium Bromide25 in 1 POUCHSOLUTION253
0781-7157-86Ipratropium Bromide1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-7157-29ML - Milliliter0781-7157513f2f97-6951-4dbf-b0ef-9aebccbb803f12012-07-24
0781-7157-64ML - Milliliter0781-71571c3f0975-45d1-42f7-8e3e-992c01d9669c12012-07-24
0781-7157-86ML - Milliliter0781-7157eaaf2fc3-e769-4d2d-8666-5644da523ac112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ipratropium BromideACTIVE INGREDIENTJ697UZ2A9JIPRATROPIUM BROMIDE SOLUTION [SANDOZ INC.]3
IpratropiumACTIVE MOIETYGR88G0I6ULIPRATROPIUM BROMIDE SOLUTION [SANDOZ INC.]3
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBIPRATROPIUM BROMIDE SOLUTION [SANDOZ INC.]3
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XIPRATROPIUM BROMIDE SOLUTION [SANDOZ INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RIPRATROPIUM BROMIDE SOLUTION [SANDOZ INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-7157IPRATROPIUM BROMIDE SOLUTION [SANDOZ INC.]3Legacy NDC, 6 package rows20130419_3984d604-3cfe-46af-b53f-34ef9b067445.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836358ipratropium bromide 0.02 % Inhalation SolutionPSN3984d604-3cfe-46af-b53f-34ef9b0674453
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD3984d604-3cfe-46af-b53f-34ef9b0674453
836358ipratropium bromide 0.02 % Inhalation SolutionSY3984d604-3cfe-46af-b53f-34ef9b0674453
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY3984d604-3cfe-46af-b53f-34ef9b0674453

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0781-7157-290078171572930 in 1 POUCHHistorical
0781-7157-64007817157641 in 1 CARTONHistorical
0781-7157-860078171578625 in 1 POUCHHistorical