ipratropium bromide

Generic: ipratropium bromide

Labeler: ritedose pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ipratropium bromide
Generic Name ipratropium bromide
Labeler ritedose pharmaceuticals, llc
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

ipratropium bromide .5 mg/2.5mL

Manufacturer
Ritedose Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 76204-100
Product ID 76204-100_459b984d-b299-c7c0-e063-6294a90a3efd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075693
Listing Expiration 2026-12-31
Marketing Start 2011-02-01

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76204100
Hyphenated Format 76204-100

Supplemental Identifiers

RxCUI
836358
UPC
0376204100250 0376204100014
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 ANDA075693 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .5 mg/2.5mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (76204-100-01) / 1 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE
  • 1 POUCH in 1 CARTON (76204-100-25) / 25 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE
  • 1 POUCH in 1 CARTON (76204-100-30) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE
  • 2 POUCH in 1 CARTON (76204-100-60) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE
source: ndc

Packages (4)

76204-100-01 30 POUCH in 1 CARTON (76204-100-01) / 1 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE 76204-100-25 1 POUCH in 1 CARTON (76204-100-25) / 25 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE 76204-100-30 1 POUCH in 1 CARTON (76204-100-30) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE 76204-100-60 2 POUCH in 1 CARTON (76204-100-60) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE

Ingredients (1)

ipratropium bromide (.5 mg/2.5mL)

Linked Drug Pages (1)

Ipratropium Bromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "459b984d-b299-c7c0-e063-6294a90a3efd", "openfda": {"upc": ["0376204100250", "0376204100014"], "unii": ["J697UZ2A9J"], "rxcui": ["836358"], "spl_set_id": ["22479633-624a-4251-ad3c-1dcba5d503fb"], "manufacturer_name": ["Ritedose Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (76204-100-01)  / 1 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE", "package_ndc": "76204-100-01", "marketing_start_date": "20111121"}, {"sample": false, "description": "1 POUCH in 1 CARTON (76204-100-25)  / 25 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE", "package_ndc": "76204-100-25", "marketing_start_date": "20111121"}, {"sample": false, "description": "1 POUCH in 1 CARTON (76204-100-30)  / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE", "package_ndc": "76204-100-30", "marketing_start_date": "20111121"}, {"sample": false, "description": "2 POUCH in 1 CARTON (76204-100-60)  / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE", "package_ndc": "76204-100-60", "marketing_start_date": "20111121"}], "brand_name": "Ipratropium Bromide", "product_id": "76204-100_459b984d-b299-c7c0-e063-6294a90a3efd", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "76204-100", "generic_name": "Ipratropium Bromide", "labeler_name": "Ritedose Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ipratropium Bromide", "active_ingredients": [{"name": "IPRATROPIUM BROMIDE", "strength": ".5 mg/2.5mL"}], "application_number": "ANDA075693", "marketing_category": "ANDA", "marketing_start_date": "20110201", "listing_expiration_date": "20261231"}