albuterol sulfate

Generic: albuterol sulfate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

albuterol sulfate 90 ug/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0742
Product ID 0054-0742_07a1b9ad-58cb-4c21-b8df-6854da990f85
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 00540742
Hyphenated Format 0054-0742

Supplemental Identifiers

RxCUI
2123111
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 (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
  • 1 CANISTER in 1 CARTON (0054-0742-87) / 200 AEROSOL, METERED in 1 CANISTER
source: ndc

Packages (1)

0054-0742-87 1 CANISTER in 1 CARTON (0054-0742-87) / 200 AEROSOL, METERED in 1 CANISTER

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": "07a1b9ad-58cb-4c21-b8df-6854da990f85", "openfda": {"unii": ["021SEF3731"], "rxcui": ["2123111"], "spl_set_id": ["6c64ab5d-f8a2-440a-a929-cb8188d0e8b4"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CANISTER in 1 CARTON (0054-0742-87)  / 200 AEROSOL, METERED in 1 CANISTER", "package_ndc": "0054-0742-87", "marketing_start_date": "20211130"}], "brand_name": "Albuterol Sulfate", "product_id": "0054-0742_07a1b9ad-58cb-4c21-b8df-6854da990f85", "dosage_form": "AEROSOL, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0054-0742", "generic_name": "Albuterol Sulfate", "labeler_name": "Hikma Pharmaceuticals 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"}