Home NDC 60505-0827 Ipratropium Bromide
Product NDC 60505-0827
11-digit product format 605050827
Labeler code 60505
Product ID 60505-0827_17e9df4b-5dd7-6d1b-d360-d55ad669069d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ipratropium bromide
Dosage form SPRAY, METERED
Route NASAL
Labeler Apotex Corp.
Application ANDA076155
Marketing category ANDA
Marketing start 2020-05-26
Substance IPRATROPIUM BROMIDE
Active strength 42 ug/1
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076155-001 IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-04-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076155-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A076155-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-04-18 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A076155-001 AB 1 a50c72e98297…
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.
Additional Listing Data#
Finished product Yes
Brand name base Ipratropium Bromide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IPRATROPIUM BROMIDE 42 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J697UZ2A9J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1797844 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-0827-1 Ipratropium Bromide 1 in 1 CARTON SPRAY, METERED 1 9 60505-0827-1 Ipratropium Bromide 165 in 1 BOTTLE, PUMP SPRAY, METERED 165 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-0827 IPRATROPIUM BROMIDE SPRAY, METERED [APOTEX CORP.] 8 Current NDC, Legacy NDC, 2 package rows 20240927_ec4c8c83-0335-544c-271e-4f27c06105ac.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60505-0827-1 60505082701 1 BOTTLE, PUMP in 1 CARTON (60505-0827-1) / 165 SPRAY, METERED in 1 BOTTLE, PUMP 2020-05-26 0000-00-00 No No Current