ipratropium bromide

Generic: ipratropium bromide

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ipratropium bromide .5 mg/2.5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-830
Product ID 62135-830_44fdbe83-0583-3b33-e063-6394a90a66db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075562
Listing Expiration 2026-12-31
Marketing Start 2001-09-27

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135830
Hyphenated Format 62135-830

Supplemental Identifiers

RxCUI
836358
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 ANDA075562 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .5 mg/2.5mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (62135-830-84) / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL
source: ndc

Packages (1)

62135-830-84 6 POUCH in 1 CARTON (62135-830-84) / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL

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": "44fdbe83-0583-3b33-e063-6394a90a66db", "openfda": {"unii": ["J697UZ2A9J"], "rxcui": ["836358"], "spl_set_id": ["1e3d4faa-cf6e-460b-b1e0-fcc8094505fa"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (62135-830-84)  / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL", "package_ndc": "62135-830-84", "marketing_start_date": "20240125"}], "brand_name": "Ipratropium Bromide", "product_id": "62135-830_44fdbe83-0583-3b33-e063-6394a90a66db", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "62135-830", "generic_name": "Ipratropium Bromide", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ipratropium Bromide", "active_ingredients": [{"name": "IPRATROPIUM BROMIDE", "strength": ".5 mg/2.5mL"}], "application_number": "ANDA075562", "marketing_category": "ANDA", "marketing_start_date": "20010927", "listing_expiration_date": "20261231"}