albuterol sulfate hfa

Generic: albuterol sulfate

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol sulfate hfa
Generic Name albuterol sulfate
Labeler advanced rx of tennessee, llc
Dosage Form AEROSOL, METERED
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate 90 ug/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0359
Product ID 80425-0359_2a996b2b-b5da-65e7-e063-6394a90adeed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020983
Listing Expiration 2026-12-31
Marketing Start 2023-09-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250359
Hyphenated Format 80425-0359

Supplemental Identifiers

RxCUI
2123076
UNII
021SEF3731

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 hfa (source: ndc)
Generic Name albuterol sulfate (source: ndc)
Application Number NDA020983 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 90 ug/1
source: ndc
Packaging
  • 1 INHALER in 1 CARTON (80425-0359-1) / 200 AEROSOL, METERED in 1 INHALER
source: ndc

Packages (1)

80425-0359-1 1 INHALER in 1 CARTON (80425-0359-1) / 200 AEROSOL, METERED in 1 INHALER

Ingredients (1)

albuterol sulfate (90 ug/1)

Linked Drug Pages (1)

Albuterol Sulfate HFA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "2a996b2b-b5da-65e7-e063-6394a90adeed", "openfda": {"unii": ["021SEF3731"], "rxcui": ["2123076"], "spl_set_id": ["04c8a345-0a0d-5a01-e063-6294a90a40d2"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 INHALER in 1 CARTON (80425-0359-1)  / 200 AEROSOL, METERED in 1 INHALER", "package_ndc": "80425-0359-1", "marketing_start_date": "20230907"}], "brand_name": "Albuterol Sulfate HFA", "product_id": "80425-0359_2a996b2b-b5da-65e7-e063-6394a90adeed", "dosage_form": "AEROSOL, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "80425-0359", "generic_name": "albuterol sulfate", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol Sulfate", "brand_name_suffix": "HFA", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "90 ug/1"}], "application_number": "NDA020983", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230907", "listing_expiration_date": "20261231"}