FDA.reportPublic FDA data

Ipratropium Bromide

Product NDC
55154-4351
11-digit product format
551544351
Labeler code
55154
Product ID
55154-4351_9336d2fe-7a40-4cdd-a297-da5ab626018c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Cardinal Health 107, LLC
Application
ANDA075562
Marketing category
ANDA
Marketing start
2001-09-27
Marketing end
2024-02-29
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55154-4351DDiscontinued by firm2026-07-31
excluded packagepackage55154-435155154-4351-5DDiscontinued 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-4351-5ML - Milliliter55154-4351cd220a71-7051-4020-9392-2be38379f3ed12018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IPRATROPIUM BROMIDEACTIVE INGREDIENTJ697UZ2A9JIPRATROPIUM BROMIDE SOLUTION [CARDINAL HEALTH]2
IPRATROPIUMACTIVE MOIETYGR88G0I6ULIPRATROPIUM BROMIDE SOLUTION [CARDINAL HEALTH]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBIPRATROPIUM BROMIDE SOLUTION [CARDINAL HEALTH]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XIPRATROPIUM BROMIDE SOLUTION [CARDINAL HEALTH]2
WATERINACTIVE INGREDIENT059QF0KO0RIPRATROPIUM BROMIDE SOLUTION [CARDINAL HEALTH]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4351-5551544351055 POUCH in 1 BAG (55154-4351-5) > 1 VIAL, SINGLE-DOSE in 1 POUCH > 2.5 mL in 1 VIAL, SINGLE-DOSE5 pouch2001-09-272024-02-29NoNoCurrent