FDA.reportPublic FDA data

Ipratropium Bromide

Product NDC
70518-2874
Requested package NDC
70518-2874-0
11-digit product format
705182874
Labeler code
70518
Product ID
70518-2874_d782c81c-81b2-3dc0-e053-2a95a90ac34c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
REMEDYREPACK INC.
Application
ANDA075562
Marketing category
ANDA
Marketing start
2020-09-09
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
2023-12-31
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 packagepackage70518-287470518-2874-0DDiscontinued 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2874-02022-02-08C16284748780-1d6a99b39-c881-a426-e053-dadaa90af4c2Ipratropium Bromide Inhalation Solution, 0.02% FOR INHALATION USE ONLY – NOT FOR INJECTION
70518-2874-02022-01-28C16284748780-1d6a99b39-c881-a426-e053-dadaa90af4c2Ipratropium Bromide Inhalation Solution, 0.02% FOR INHALATION USE ONLY – NOT FOR INJECTION

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2874-0705182874002 POUCH in 1 CARTON (70518-2874-0) > 30 VIAL, SINGLE-DOSE in 1 POUCH > 2.5 mL in 1 VIAL, SINGLE-DOSE2 pouch2020-09-090000-00-00NoNoCurrent