albuterol sulfate inhalation solution

Generic: albuterol sulfate

Labeler: ritedose pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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 1.25 mg/3mL

Manufacturer
Ritedose Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 76204-011
Product ID 76204-011_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 76204011
Hyphenated Format 76204-011

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
  • 1.25 mg/3mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (76204-011-01) / 1 VIAL in 1 POUCH (76204-011-11) / 3 mL in 1 VIAL
  • 25 POUCH in 1 CARTON (76204-011-55) / 5 VIAL in 1 POUCH (76204-011-05) / 3 mL in 1 VIAL
source: ndc

Packages (2)

76204-011-01 30 POUCH in 1 CARTON (76204-011-01) / 1 VIAL in 1 POUCH (76204-011-11) / 3 mL in 1 VIAL 76204-011-55 25 POUCH in 1 CARTON (76204-011-55) / 5 VIAL in 1 POUCH (76204-011-05) / 3 mL in 1 VIAL

Ingredients (1)

albuterol sulfate (1.25 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 (76204-011-01)  / 1 VIAL in 1 POUCH (76204-011-11)  / 3 mL in 1 VIAL", "package_ndc": "76204-011-01", "marketing_start_date": "20220104"}, {"sample": false, "description": "25 POUCH in 1 CARTON (76204-011-55)  / 5 VIAL in 1 POUCH (76204-011-05)  / 3 mL in 1 VIAL", "package_ndc": "76204-011-55", "marketing_start_date": "20220104"}], "brand_name": "Albuterol Sulfate Inhalation Solution", "product_id": "76204-011_459fa821-0926-fbe9-e063-6394a90ac084", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "76204-011", "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": "1.25 mg/3mL"}], "application_number": "ANDA214531", "marketing_category": "ANDA", "marketing_start_date": "20220104", "listing_expiration_date": "20261231"}