ipratropium bromide and albuterol sulfate (0487-0201)

Drug Facts

Product Profile

Brand Name ipratropium bromide and albuterol sulfate

Generic Name ipratropium bromide and albuterol sulfate

Labeler nephron pharmaceuticals corporation

Dosage Form SOLUTION

Routes

RESPIRATORY (INHALATION)

Active Ingredients

albuterol sulfate 3 mg/3mL, ipratropium bromide .5 mg/3mL

Manufacturer

Nephron Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0487-0201

Product ID 0487-0201_32473735-b131-709c-e063-6294a90afde8

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA076749

Listing Expiration 2026-12-31

Marketing Start 2007-12-31

Pharmacologic Class

Classes

adrenergic beta2-agonists [moa] anticholinergic [epc] cholinergic antagonists [moa] beta2-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04870201

Hyphenated Format 0487-0201

Supplemental Identifiers

RxCUI

1437702

UPC

0304870201018

UNII

021SEF3731 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 and albuterol sulfate (source: ndc)

Generic Name ipratropium bromide and albuterol sulfate (source: ndc)

Application Number ANDA076749 (source: ndc)

Routes

RESPIRATORY (INHALATION)

source: ndc

Resolved Composition

Strengths

3 mg/3mL
.5 mg/3mL

source: ndc

Packaging

30 POUCH in 1 CARTON (0487-0201-01) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE
30 POUCH in 1 CARTON (0487-0201-02) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE
6 POUCH in 1 CARTON (0487-0201-03) / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE
12 POUCH in 1 CARTON (0487-0201-60) / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE

source: ndc

Packages (4)

0487-0201-01 30 POUCH in 1 CARTON (0487-0201-01) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE 0487-0201-02 30 POUCH in 1 CARTON (0487-0201-02) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE 0487-0201-03 6 POUCH in 1 CARTON (0487-0201-03) / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE 0487-0201-60 12 POUCH in 1 CARTON (0487-0201-60) / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE

Ingredients (2)

albuterol sulfate (3 mg/3mL) ipratropium bromide (.5 mg/3mL)

Linked Drug Pages (1)

Ipratropium Bromide and Albuterol Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "32473735-b131-709c-e063-6294a90afde8", "openfda": {"upc": ["0304870201018"], "unii": ["021SEF3731", "J697UZ2A9J"], "rxcui": ["1437702"], "spl_set_id": ["ae35ec1f-526a-49bf-8262-c50e40190d1f"], "manufacturer_name": ["Nephron Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (0487-0201-01)  / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0487-0201-01", "marketing_start_date": "20071231"}, {"sample": false, "description": "30 POUCH in 1 CARTON (0487-0201-02)  / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0487-0201-02", "marketing_start_date": "20071231"}, {"sample": false, "description": "6 POUCH in 1 CARTON (0487-0201-03)  / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0487-0201-03", "marketing_start_date": "20071231"}, {"sample": false, "description": "12 POUCH in 1 CARTON (0487-0201-60)  / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0487-0201-60", "marketing_start_date": "20071231"}], "brand_name": "Ipratropium Bromide and Albuterol Sulfate", "product_id": "0487-0201_32473735-b131-709c-e063-6294a90afde8", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0487-0201", "generic_name": "Ipratropium Bromide and Albuterol Sulfate", "labeler_name": "Nephron Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ipratropium Bromide and Albuterol Sulfate", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "3 mg/3mL"}, {"name": "IPRATROPIUM BROMIDE", "strength": ".5 mg/3mL"}], "application_number": "ANDA076749", "marketing_category": "ANDA", "marketing_start_date": "20071231", "listing_expiration_date": "20261231"}