ipratropium bromide and albuterol sulfate (64980-645)

Drug Facts

Product Profile

Brand Name ipratropium bromide and albuterol sulfate

Generic Name ipratropium bromide and albuterol sulfate

Labeler rising pharma holdings, inc.

Dosage Form SOLUTION

Routes

RESPIRATORY (INHALATION)

Active Ingredients

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

Manufacturer

Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-645

Product ID 64980-645_3246ea9c-eac0-4088-e063-6294a90a8cf8

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA076749

Listing Expiration 2026-12-31

Marketing Start 2025-03-14

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 64980645

Hyphenated Format 64980-645

Supplemental Identifiers

RxCUI

1437702

UPC

0364980645003

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 (64980-645-03) / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE
60 POUCH in 1 CARTON (64980-645-06) / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE

source: ndc

Packages (2)

64980-645-03 30 POUCH in 1 CARTON (64980-645-03) / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE 64980-645-06 60 POUCH in 1 CARTON (64980-645-06) / 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": "3246ea9c-eac0-4088-e063-6294a90a8cf8", "openfda": {"upc": ["0364980645003"], "unii": ["021SEF3731", "J697UZ2A9J"], "rxcui": ["1437702"], "spl_set_id": ["3246dfab-61d7-27ba-e063-6294a90ac180"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (64980-645-03)  / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE", "package_ndc": "64980-645-03", "marketing_start_date": "20250314"}, {"sample": false, "description": "60 POUCH in 1 CARTON (64980-645-06)  / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE", "package_ndc": "64980-645-06", "marketing_start_date": "20250314"}], "brand_name": "Ipratropium Bromide and Albuterol Sulfate", "product_id": "64980-645_3246ea9c-eac0-4088-e063-6294a90a8cf8", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "64980-645", "generic_name": "Ipratropium Bromide and Albuterol Sulfate", "labeler_name": "Rising Pharma Holdings, 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": "20250314", "listing_expiration_date": "20261231"}