ipratropium bromide and albuterol sulfate

Generic: ipratropium bromide and albuterol sulfate

Labeler: american health packaging
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 american health packaging
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

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

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-405
Product ID 60687-405_1a02568a-4fa8-5ec8-e063-6294a90a1558
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202496
Listing Expiration 2026-12-31
Marketing Start 2019-01-21

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 60687405
Hyphenated Format 60687-405

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 ANDA202496 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/3mL
  • .5 mg/3mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (60687-405-83) / 1 AMPULE in 1 POUCH (60687-405-79) / 3 mL in 1 AMPULE
source: ndc

Packages (1)

60687-405-83 30 POUCH in 1 CARTON (60687-405-83) / 1 AMPULE in 1 POUCH (60687-405-79) / 3 mL in 1 AMPULE

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": "1a02568a-4fa8-5ec8-e063-6294a90a1558", "openfda": {"unii": ["021SEF3731", "J697UZ2A9J"], "rxcui": ["1437702"], "spl_set_id": ["c04c6ec8-1401-424d-8126-63080e36c4b9"], "manufacturer_name": ["American Health Packaging"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (60687-405-83)  / 1 AMPULE in 1 POUCH (60687-405-79)  / 3 mL in 1 AMPULE", "package_ndc": "60687-405-83", "marketing_start_date": "20190121"}], "brand_name": "IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE", "product_id": "60687-405_1a02568a-4fa8-5ec8-e063-6294a90a1558", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "60687-405", "generic_name": "Ipratropium Bromide and Albuterol Sulfate", "labeler_name": "American Health Packaging", "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": "ANDA202496", "marketing_category": "ANDA", "marketing_start_date": "20190121", "listing_expiration_date": "20261231"}