ipratropium bromide

Generic: ipratropium bromide

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ipratropium bromide
Generic Name ipratropium bromide
Labeler amneal pharmaceuticals ny llc
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

ipratropium bromide 21 ug/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-2016
Product ID 69238-2016_1c1d7d62-9ebf-49eb-9eb2-471f9ce73637
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215104
Listing Expiration 2026-12-31
Marketing Start 2022-08-18

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692382016
Hyphenated Format 69238-2016

Supplemental Identifiers

RxCUI
1797833
UPC
0369238201635
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 ANDA215104 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 21 ug/1
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (69238-2016-3) / 345 SPRAY in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

69238-2016-3 1 BOTTLE, SPRAY in 1 CARTON (69238-2016-3) / 345 SPRAY in 1 BOTTLE, SPRAY

Ingredients (1)

ipratropium bromide (21 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": "1c1d7d62-9ebf-49eb-9eb2-471f9ce73637", "openfda": {"upc": ["0369238201635"], "unii": ["J697UZ2A9J"], "rxcui": ["1797833"], "spl_set_id": ["61820346-29d9-4864-b8f4-4a198b8ac594"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (69238-2016-3)  / 345 SPRAY in 1 BOTTLE, SPRAY", "package_ndc": "69238-2016-3", "marketing_start_date": "20220818"}], "brand_name": "Ipratropium Bromide", "product_id": "69238-2016_1c1d7d62-9ebf-49eb-9eb2-471f9ce73637", "dosage_form": "SPRAY", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "69238-2016", "generic_name": "Ipratropium Bromide", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ipratropium Bromide", "active_ingredients": [{"name": "IPRATROPIUM BROMIDE", "strength": "21 ug/1"}], "application_number": "ANDA215104", "marketing_category": "ANDA", "marketing_start_date": "20220818", "listing_expiration_date": "20261231"}