ipratropium bromide

Generic: ipratropium bromide

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ipratropium bromide
Generic Name ipratropium bromide
Labeler aurobindo pharma limited
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

ipratropium bromide .5 mg/2.5mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-905
Product ID 65862-905_08eada61-404a-b5f8-e063-6294a90a74e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206543
Listing Expiration 2026-12-31
Marketing Start 2016-10-27

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862905
Hyphenated Format 65862-905

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 ANDA206543 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .5 mg/2.5mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (65862-905-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE
  • 1 POUCH in 1 CARTON (65862-905-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE
  • 1 POUCH in 1 CARTON (65862-905-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-33) / 2.5 mL in 1 VIAL, SINGLE-DOSE
  • 2 POUCH in 1 CARTON (65862-905-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (4)

65862-905-03 30 POUCH in 1 CARTON (65862-905-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE 65862-905-25 1 POUCH in 1 CARTON (65862-905-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE 65862-905-30 1 POUCH in 1 CARTON (65862-905-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-33) / 2.5 mL in 1 VIAL, SINGLE-DOSE 65862-905-60 2 POUCH in 1 CARTON (65862-905-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE

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": "08eada61-404a-b5f8-e063-6294a90a74e7", "openfda": {"unii": ["J697UZ2A9J"], "rxcui": ["836358"], "spl_set_id": ["ff2b6bda-4acd-41fd-8970-458c5265df21"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (65862-905-03)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-01)  / 2.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65862-905-03", "marketing_start_date": "20161027"}, {"sample": false, "description": "1 POUCH in 1 CARTON (65862-905-25)  / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65862-905-25", "marketing_start_date": "20161027"}, {"sample": false, "description": "1 POUCH in 1 CARTON (65862-905-30)  / 30 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-33)  / 2.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65862-905-30", "marketing_start_date": "20161027"}, {"sample": false, "description": "2 POUCH in 1 CARTON (65862-905-60)  / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65862-905-60", "marketing_start_date": "20161027"}], "brand_name": "Ipratropium bromide", "product_id": "65862-905_08eada61-404a-b5f8-e063-6294a90a74e7", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "65862-905", "generic_name": "Ipratropium bromide", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ipratropium bromide", "active_ingredients": [{"name": "IPRATROPIUM BROMIDE", "strength": ".5 mg/2.5mL"}], "application_number": "ANDA206543", "marketing_category": "ANDA", "marketing_start_date": "20161027", "listing_expiration_date": "20261231"}