Home NDC 0054-0045 Ipratropium Bromide
Product NDC 0054-0045
11-digit product format 000540045
Labeler code 0054
Product ID 0054-0045_c8dbb0db-5c00-4205-a765-d664117c4398
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ipratropium Bromide
Dosage form SPRAY
Route NASAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA076664
Marketing category ANDA
Marketing start 2003-11-05
Substance IPRATROPIUM BROMIDE
Active strength 21 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 A076664-001 IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076664-001 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 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 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 A076664-001 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 · 2 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 21 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 1797833 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 0054-0045-44 Ipratropium Bromide 1 in 1 CARTON SPRAY 1 13 0054-0045-44 Ipratropium Bromide 345 in 1 BOTTLE, SPRAY SPRAY 345 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IPRATROPIUM BROMIDE ACTIVE INGREDIENT J697UZ2A9J IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9 IPRATROPIUM ACTIVE MOIETY GR88G0I6UL IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9 EDETATE CALCIUM DISODIUM INACTIVE INGREDIENT 25IH6R4SGF IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9 HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) INACTIVE INGREDIENT 8136Y38GY5 IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9 WATER INACTIVE INGREDIENT 059QF0KO0R IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0045 IPRATROPIUM BROMIDE SPRAY [HIKMA PHARMACEUTICALS USA INC.] 13 Current NDC, Legacy NDC, 2 package rows 20240209_05c56190-e346-4674-a4f8-049ce632ce2d.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 0054-0045-44 00054004544 1 BOTTLE, SPRAY in 1 CARTON (0054-0045-44) / 345 SPRAY in 1 BOTTLE, SPRAY 2003-11-05 0000-00-00 No No Current