ipratropium bromide and albuterol sulfate

Generic: ipratropium bromide and albuterol sulfate

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

Drug Facts

Product Profile

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

albuterol sulfate 2.5 mg/3mL, ipratropium bromide .5 mg/3mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-756
Product ID 47335-756_c9e56721-a62e-4703-8ea6-20bf51f244a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207875
Listing Expiration 2026-12-31
Marketing Start 2021-11-15

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 47335756
Hyphenated Format 47335-756

Supplemental Identifiers

RxCUI
1437702
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 ANDA207875 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/3mL
  • .5 mg/3mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (47335-756-49) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL
  • 12 POUCH in 1 CARTON (47335-756-52) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL
source: ndc

Packages (2)

47335-756-49 6 POUCH in 1 CARTON (47335-756-49) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL 47335-756-52 12 POUCH in 1 CARTON (47335-756-52) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL

Ingredients (2)

albuterol sulfate (2.5 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": "c9e56721-a62e-4703-8ea6-20bf51f244a6", "openfda": {"unii": ["021SEF3731", "J697UZ2A9J"], "rxcui": ["1437702"], "spl_set_id": ["38f9a201-3954-4370-8e71-7ec2df88a1ff"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (47335-756-49)  / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL", "package_ndc": "47335-756-49", "marketing_start_date": "20211115"}, {"sample": false, "description": "12 POUCH in 1 CARTON (47335-756-52)  / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL", "package_ndc": "47335-756-52", "marketing_start_date": "20211115"}], "brand_name": "Ipratropium Bromide and Albuterol Sulfate", "product_id": "47335-756_c9e56721-a62e-4703-8ea6-20bf51f244a6", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "47335-756", "generic_name": "Ipratropium Bromide and Albuterol Sulfate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ipratropium Bromide and Albuterol Sulfate", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "2.5 mg/3mL"}, {"name": "IPRATROPIUM BROMIDE", "strength": ".5 mg/3mL"}], "application_number": "ANDA207875", "marketing_category": "ANDA", "marketing_start_date": "20211115", "listing_expiration_date": "20261231"}