ipratropium bromide and albuterol sulfate

Generic: ipratropium bromide and albuterol sulfate

Labeler: preferred pharmaceuticals 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 preferred pharmaceuticals inc.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

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

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8103
Product ID 68788-8103_23668386-c4a9-4eb0-804e-28f204969850
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076749
Listing Expiration 2026-12-31
Marketing Start 2021-10-14

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 687888103
Hyphenated Format 68788-8103

Supplemental Identifiers

RxCUI
1437702
UNII
021SEF3731 J697UZ2A9J

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 (68788-8103-3) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

68788-8103-3 30 POUCH in 1 CARTON (68788-8103-3) / 1 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": "23668386-c4a9-4eb0-804e-28f204969850", "openfda": {"unii": ["021SEF3731", "J697UZ2A9J"], "rxcui": ["1437702"], "spl_set_id": ["66f32a06-c880-4b5b-837b-951e1e01e040"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (68788-8103-3)  / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE", "package_ndc": "68788-8103-3", "marketing_start_date": "20211014"}], "brand_name": "Ipratropium Bromide and Albuterol Sulfate", "product_id": "68788-8103_23668386-c4a9-4eb0-804e-28f204969850", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "68788-8103", "generic_name": "Ipratropium Bromide and Albuterol Sulfate", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "20211014", "listing_expiration_date": "20261231"}