FDA.reportPublic FDA data

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#

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-418550090-4185-0IInactivated 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
A075562-001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONAN2001-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075562-001AN

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 22:54:322026-06A075562-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONAN2001-09-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075562-001AN1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ipratropium BromideIPRATROPIUM BROMIDERising Pharma Holdings, Inc.3249aea8-a395-f09f-e063-6294a90a2d8b2026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075562
application number: ANDA075562
Ipratropium BromideIPRATROPIUM BROMIDEChartwell RX, LLC1e3d4faa-cf6e-460b-b1e0-fcc8094505fa2025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075562
application number: ANDA075562
Ipratropium BromideIPRATROPIUM BROMIDENephron Pharmaceuticals Corporationdb8095db-d1fd-4099-9fb1-d1ad4e2849762025-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075562
application number: ANDA075562

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
50090-4185-02023-01-30C16284748780-1f386c64a-371d-0266-e053-dadaa90a7c1aIpratropium Bromide Inhalation Solution, 0.02% FOR INHALATION USE ONLY – NOT FOR INJECTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4185-0Ipratropium Bromide1 in 1 CARTONSOLUTION12
50090-4185-0Ipratropium Bromide25 mL in 1 POUCHSOLUTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4185IPRATROPIUM BROMIDE SOLUTION [A-S MEDICATION SOLUTIONS]2Legacy NDC, 2 package rows20190601_9eb6a1c2-1e95-4926-a684-b53b8bc95ebd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836358ipratropium bromide 0.02 % Inhalation SolutionPSN9eb6a1c2-1e95-4926-a684-b53b8bc95ebd2
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD9eb6a1c2-1e95-4926-a684-b53b8bc95ebd2
836358ipratropium bromide 0.02 % Inhalation SolutionSY9eb6a1c2-1e95-4926-a684-b53b8bc95ebd2
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY9eb6a1c2-1e95-4926-a684-b53b8bc95ebd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4185-0500904185001 POUCH in 1 CARTON (50090-4185-0) > 25 mL in 1 POUCH1 pouch2019-03-140000-00-00NoNoCurrent