ipratropium bromide

Generic: ipratropium bromide

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ipratropium bromide
Generic Name ipratropium bromide
Labeler hikma pharmaceuticals usa inc.
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

ipratropium bromide 42 ug/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0046
Product ID 0054-0046_1af1d74f-a67d-450a-ab96-1021079f5a35
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076598
Listing Expiration 2026-12-31
Marketing Start 2003-11-05

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540046
Hyphenated Format 0054-0046

Supplemental Identifiers

RxCUI
1797844
UNII
J697UZ2A9J

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ipratropium bromide (source: ndc)
Generic Name ipratropium bromide (source: ndc)
Application Number ANDA076598 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 42 ug/1
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (0054-0046-41) / 165 SPRAY in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

0054-0046-41 1 BOTTLE, SPRAY in 1 CARTON (0054-0046-41) / 165 SPRAY in 1 BOTTLE, SPRAY

Ingredients (1)

ipratropium bromide (42 ug/1)

Linked Drug Pages (1)

Ipratropium Bromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "1af1d74f-a67d-450a-ab96-1021079f5a35", "openfda": {"unii": ["J697UZ2A9J"], "rxcui": ["1797844"], "spl_set_id": ["71bdbbb9-8696-416d-bed4-7259929c0161"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (0054-0046-41)  / 165 SPRAY in 1 BOTTLE, SPRAY", "package_ndc": "0054-0046-41", "marketing_start_date": "20031105"}], "brand_name": "Ipratropium Bromide", "product_id": "0054-0046_1af1d74f-a67d-450a-ab96-1021079f5a35", "dosage_form": "SPRAY", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0054-0046", "generic_name": "Ipratropium Bromide", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ipratropium Bromide", "active_ingredients": [{"name": "IPRATROPIUM BROMIDE", "strength": "42 ug/1"}], "application_number": "ANDA076598", "marketing_category": "ANDA", "marketing_start_date": "20031105", "listing_expiration_date": "20261231"}