ipratropium bromide

Generic: ipratropium bromide

Labeler: nephron pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ipratropium bromide
Generic Name ipratropium bromide
Labeler nephron pharmaceuticals corporation
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

ipratropium bromide .5 mg/2.5mL

Manufacturer
Nephron Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0487-9801
Product ID 0487-9801_3249e47e-0ac1-e2a5-e063-6394a90a9993
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 04879801
Hyphenated Format 0487-9801

Supplemental Identifiers

RxCUI
836358
UPC
0304879801011 0304879801004
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
  • 30 POUCH in 1 CARTON (0487-9801-01) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE
  • 30 BAG in 1 BOX (0487-9801-02) / 1 POUCH in 1 BAG / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE
  • 1 POUCH in 1 CARTON (0487-9801-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE
  • 1 POUCH in 1 CARTON (0487-9801-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE
  • 2 POUCH in 1 CARTON (0487-9801-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (5)

0487-9801-01 30 POUCH in 1 CARTON (0487-9801-01) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE 0487-9801-02 30 BAG in 1 BOX (0487-9801-02) / 1 POUCH in 1 BAG / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE 0487-9801-25 1 POUCH in 1 CARTON (0487-9801-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE 0487-9801-30 1 POUCH in 1 CARTON (0487-9801-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE 0487-9801-60 2 POUCH in 1 CARTON (0487-9801-60) / 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": "3249e47e-0ac1-e2a5-e063-6394a90a9993", "openfda": {"upc": ["0304879801011", "0304879801004"], "unii": ["J697UZ2A9J"], "rxcui": ["836358"], "spl_set_id": ["db8095db-d1fd-4099-9fb1-d1ad4e284976"], "manufacturer_name": ["Nephron Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (0487-9801-01)  / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0487-9801-01", "marketing_start_date": "20010927"}, {"sample": false, "description": "30 BAG in 1 BOX (0487-9801-02)  / 1 POUCH in 1 BAG / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0487-9801-02", "marketing_start_date": "20010927"}, {"sample": false, "description": "1 POUCH in 1 CARTON (0487-9801-25)  / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0487-9801-25", "marketing_start_date": "20010927"}, {"sample": false, "description": "1 POUCH in 1 CARTON (0487-9801-30)  / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0487-9801-30", "marketing_start_date": "20010927"}, {"sample": false, "description": "2 POUCH in 1 CARTON (0487-9801-60)  / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0487-9801-60", "marketing_start_date": "20010927"}], "brand_name": "Ipratropium Bromide", "product_id": "0487-9801_3249e47e-0ac1-e2a5-e063-6394a90a9993", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0487-9801", "generic_name": "Ipratropium Bromide", "labeler_name": "Nephron Pharmaceuticals Corporation", "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"}