albuterol sulfate inhalation solution, 0.5%

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, 0.5%
Generic Name albuterol sulfate
Labeler ritedose pharmaceuticals, llc
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate 2.5 mg/.5mL

Manufacturer
Ritedose Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 76204-027
Product ID 76204-027_459fafb6-451d-4f51-e063-6294a90a93f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218386
Listing Expiration 2026-12-31
Marketing Start 2025-03-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76204027
Hyphenated Format 76204-027

Supplemental Identifiers

RxCUI
245314
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, 0.5% (source: ndc)
Generic Name albuterol sulfate (source: ndc)
Application Number ANDA218386 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/.5mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (76204-027-01) / 1 VIAL in 1 POUCH (76204-027-11) / .5 mL in 1 VIAL
source: ndc

Packages (1)

76204-027-01 30 POUCH in 1 CARTON (76204-027-01) / 1 VIAL in 1 POUCH (76204-027-11) / .5 mL in 1 VIAL

Ingredients (1)

albuterol sulfate (2.5 mg/.5mL)

Linked Drug Pages (1)

Albuterol Sulfate Inhalation Solution, 0.5% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "459fafb6-451d-4f51-e063-6294a90a93f9", "openfda": {"unii": ["021SEF3731"], "rxcui": ["245314"], "spl_set_id": ["fdb4ac5a-bf0d-4896-89f7-1828c081b79e"], "manufacturer_name": ["Ritedose Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (76204-027-01)  / 1 VIAL in 1 POUCH (76204-027-11)  / .5 mL in 1 VIAL", "package_ndc": "76204-027-01", "marketing_start_date": "20250324"}], "brand_name": "Albuterol Sulfate Inhalation Solution, 0.5%", "product_id": "76204-027_459fafb6-451d-4f51-e063-6294a90a93f9", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "76204-027", "generic_name": "Albuterol Sulfate", "labeler_name": "Ritedose Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol Sulfate Inhalation Solution, 0.5%", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "2.5 mg/.5mL"}], "application_number": "ANDA218386", "marketing_category": "ANDA", "marketing_start_date": "20250324", "listing_expiration_date": "20261231"}