Home NDC 72888-148 IPRATROPIUM BROMIDE
Product NDC 72888-148
11-digit product format 728880148
Labeler code 72888
Product ID 72888-148_45c7c86f-7829-b9bb-e063-6294a90a680a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IPRATROPIUM BROMIDE
Dosage form SPRAY, METERED
Route NASAL
Labeler Advagen Pharma Ltd
Application ANDA219221
Marketing category ANDA
Marketing start 2024-11-15
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 A219221-001 IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2024-11-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219221-001 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 A219221-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2024-11-15 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 A219221-001 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 · 1 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 72888-148-37 IPRATROPIUM BROMIDE 1 in 1 CARTON SPRAY, METERED 1 3 72888-148-37 IPRATROPIUM BROMIDE 165 in 1 BOTTLE SPRAY, METERED 165 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72888-148 IPRATROPIUM BROMIDE SPRAY, METERED [ADVAGEN PHARMA LTD] 1 Current NDC, 2 package rows 20241129_bb5f7711-595f-4f7c-9e89-66d029ccbccb.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72888-148-37 72888014837 1 BOTTLE in 1 CARTON (72888-148-37) / 165 SPRAY, METERED in 1 BOTTLE 1 bottle 2024-11-15 No No Current