albuterol sulfate inhalation solution (76204-010)

Drug Facts

Product Profile

Brand Name albuterol sulfate inhalation solution

Generic Name albuterol sulfate

Labeler ritedose pharmaceuticals, llc

Dosage Form SOLUTION

Routes

RESPIRATORY (INHALATION)

Active Ingredients

albuterol sulfate .63 mg/3mL

Manufacturer

Ritedose Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 76204-010

Product ID 76204-010_459fa821-0926-fbe9-e063-6394a90ac084

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214531

Listing Expiration 2026-12-31

Marketing Start 2022-01-04

Pharmacologic Class

Classes

adrenergic beta2-agonists [moa] beta2-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76204010

Hyphenated Format 76204-010

Supplemental Identifiers

RxCUI

351136 351137

UNII

021SEF3731

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 albuterol sulfate inhalation solution (source: ndc)

Generic Name albuterol sulfate (source: ndc)

Application Number ANDA214531 (source: ndc)

Routes

RESPIRATORY (INHALATION)

source: ndc

Resolved Composition

Strengths

.63 mg/3mL

source: ndc

Packaging

30 POUCH in 1 CARTON (76204-010-01) / 1 VIAL in 1 POUCH (76204-010-11) / 3 mL in 1 VIAL
25 POUCH in 1 CARTON (76204-010-55) / 5 VIAL in 1 POUCH (76204-010-05) / 3 mL in 1 VIAL

source: ndc

Packages (2)

76204-010-01 30 POUCH in 1 CARTON (76204-010-01) / 1 VIAL in 1 POUCH (76204-010-11) / 3 mL in 1 VIAL 76204-010-55 25 POUCH in 1 CARTON (76204-010-55) / 5 VIAL in 1 POUCH (76204-010-05) / 3 mL in 1 VIAL

Ingredients (1)

albuterol sulfate (.63 mg/3mL)

Linked Drug Pages (1)

Albuterol Sulfate Inhalation Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "459fa821-0926-fbe9-e063-6394a90ac084", "openfda": {"unii": ["021SEF3731"], "rxcui": ["351136", "351137"], "spl_set_id": ["d4c532be-1f41-60d3-e053-2995a90a98be"], "manufacturer_name": ["Ritedose Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (76204-010-01)  / 1 VIAL in 1 POUCH (76204-010-11)  / 3 mL in 1 VIAL", "package_ndc": "76204-010-01", "marketing_start_date": "20220104"}, {"sample": false, "description": "25 POUCH in 1 CARTON (76204-010-55)  / 5 VIAL in 1 POUCH (76204-010-05)  / 3 mL in 1 VIAL", "package_ndc": "76204-010-55", "marketing_start_date": "20220104"}], "brand_name": "Albuterol Sulfate Inhalation Solution", "product_id": "76204-010_459fa821-0926-fbe9-e063-6394a90ac084", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "76204-010", "generic_name": "Albuterol Sulfate", "labeler_name": "Ritedose Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol Sulfate Inhalation Solution", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": ".63 mg/3mL"}], "application_number": "ANDA214531", "marketing_category": "ANDA", "marketing_start_date": "20220104", "listing_expiration_date": "20261231"}