ipratropium bromide and albuterol sulfate (0378-9671)

Drug Facts

Product Profile

Brand Name ipratropium bromide and albuterol sulfate

Generic Name ipratropium bromide and albuterol sulfate

Labeler mylan pharmaceuticals inc.

Dosage Form SOLUTION

Routes

RESPIRATORY (INHALATION)

Active Ingredients

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

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-9671

Product ID 0378-9671_96603d2c-6783-4f6c-8b3e-de3eaabcc6aa

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202496

Listing Expiration 2026-12-31

Marketing Start 2013-03-01

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 03789671

Hyphenated Format 0378-9671

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

1 POUCH in 1 CARTON (0378-9671-30) / 30 AMPULE in 1 POUCH (0378-9671-64) / 3 mL in 1 AMPULE
2 POUCH in 1 CARTON (0378-9671-60) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE
30 POUCH in 1 CARTON (0378-9671-93) / 1 AMPULE in 1 POUCH (0378-9671-31) / 3 mL in 1 AMPULE

source: ndc

Packages (3)

0378-9671-30 1 POUCH in 1 CARTON (0378-9671-30) / 30 AMPULE in 1 POUCH (0378-9671-64) / 3 mL in 1 AMPULE 0378-9671-60 2 POUCH in 1 CARTON (0378-9671-60) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE 0378-9671-93 30 POUCH in 1 CARTON (0378-9671-93) / 1 AMPULE in 1 POUCH (0378-9671-31) / 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": "96603d2c-6783-4f6c-8b3e-de3eaabcc6aa", "openfda": {"unii": ["021SEF3731", "J697UZ2A9J"], "rxcui": ["1437702"], "spl_set_id": ["23c05e9a-9df5-4978-8831-cf562aa4ba92"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (0378-9671-30)  / 30 AMPULE in 1 POUCH (0378-9671-64)  / 3 mL in 1 AMPULE", "package_ndc": "0378-9671-30", "marketing_start_date": "20130301"}, {"sample": false, "description": "2 POUCH in 1 CARTON (0378-9671-60)  / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE", "package_ndc": "0378-9671-60", "marketing_start_date": "20130301"}, {"sample": false, "description": "30 POUCH in 1 CARTON (0378-9671-93)  / 1 AMPULE in 1 POUCH (0378-9671-31)  / 3 mL in 1 AMPULE", "package_ndc": "0378-9671-93", "marketing_start_date": "20130301"}], "brand_name": "Ipratropium Bromide and Albuterol Sulfate", "product_id": "0378-9671_96603d2c-6783-4f6c-8b3e-de3eaabcc6aa", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0378-9671", "generic_name": "Ipratropium Bromide and Albuterol Sulfate", "labeler_name": "Mylan Pharmaceuticals 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": "ANDA202496", "marketing_category": "ANDA", "marketing_start_date": "20130301", "listing_expiration_date": "20261231"}