ipratropium bromide

Generic: ipratropium bromide

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ipratropium bromide
Generic Name ipratropium bromide
Labeler sun pharmaceutical industries, inc.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

ipratropium bromide .5 mg/2.5mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-706
Product ID 47335-706_147b55d9-c9f9-4a22-814a-acf834a1864d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207903
Listing Expiration 2026-12-31
Marketing Start 2020-02-04

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335706
Hyphenated Format 47335-706

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 ANDA207903 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .5 mg/2.5mL
source: ndc
Packaging
  • 5 POUCH in 1 CARTON (47335-706-49) / 5 VIAL in 1 POUCH (47335-706-48) / 2.5 mL in 1 VIAL
  • 6 POUCH in 1 CARTON (47335-706-52) / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL
  • 12 POUCH in 1 CARTON (47335-706-54) / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL
source: ndc

Packages (3)

47335-706-49 5 POUCH in 1 CARTON (47335-706-49) / 5 VIAL in 1 POUCH (47335-706-48) / 2.5 mL in 1 VIAL 47335-706-52 6 POUCH in 1 CARTON (47335-706-52) / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL 47335-706-54 12 POUCH in 1 CARTON (47335-706-54) / 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": "147b55d9-c9f9-4a22-814a-acf834a1864d", "openfda": {"unii": ["J697UZ2A9J"], "rxcui": ["836358"], "spl_set_id": ["231ae8f2-1ec9-4e0f-90a8-11d7b6222576"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (47335-706-49)  / 5 VIAL in 1 POUCH (47335-706-48)  / 2.5 mL in 1 VIAL", "package_ndc": "47335-706-49", "marketing_start_date": "20200204"}, {"sample": false, "description": "6 POUCH in 1 CARTON (47335-706-52)  / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL", "package_ndc": "47335-706-52", "marketing_start_date": "20200204"}, {"sample": false, "description": "12 POUCH in 1 CARTON (47335-706-54)  / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL", "package_ndc": "47335-706-54", "marketing_start_date": "20200204"}], "brand_name": "Ipratropium Bromide", "product_id": "47335-706_147b55d9-c9f9-4a22-814a-acf834a1864d", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "47335-706", "generic_name": "Ipratropium Bromide", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ipratropium Bromide", "active_ingredients": [{"name": "IPRATROPIUM BROMIDE", "strength": ".5 mg/2.5mL"}], "application_number": "ANDA207903", "marketing_category": "ANDA", "marketing_start_date": "20200204", "listing_expiration_date": "20261231"}