albuterol sulfate

Generic: albuterol sulfate

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol sulfate
Generic Name albuterol sulfate
Labeler asclemed usa, inc.
Dosage Form AEROSOL, METERED
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate 90 ug/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-531
Product ID 76420-531_f104fd15-0d76-3db4-e053-2995a90a1a88
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207085
Listing Expiration 2026-12-31
Marketing Start 2021-11-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420531
Hyphenated Format 76420-531

Supplemental Identifiers

RxCUI
2123111
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 (source: ndc)
Generic Name albuterol sulfate (source: ndc)
Application Number ANDA207085 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 90 ug/1
source: ndc
Packaging
  • 200 AEROSOL, METERED in 1 CANISTER (76420-531-01)
source: ndc

Packages (1)

76420-531-01 200 AEROSOL, METERED in 1 CANISTER (76420-531-01)

Ingredients (1)

albuterol sulfate (90 ug/1)

Linked Drug Pages (1)

Albuterol Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "f104fd15-0d76-3db4-e053-2995a90a1a88", "openfda": {"unii": ["021SEF3731"], "rxcui": ["2123111"], "spl_set_id": ["87ff8be7-3a49-44bd-92de-eb8db24af95b"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "200 AEROSOL, METERED in 1 CANISTER (76420-531-01)", "package_ndc": "76420-531-01", "marketing_start_date": "20221213"}], "brand_name": "Albuterol Sulfate", "product_id": "76420-531_f104fd15-0d76-3db4-e053-2995a90a1a88", "dosage_form": "AEROSOL, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "76420-531", "generic_name": "Albuterol Sulfate", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol Sulfate", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "90 ug/1"}], "application_number": "ANDA207085", "marketing_category": "ANDA", "marketing_start_date": "20211130", "listing_expiration_date": "20261231"}