albuterol sulfate

Generic: albuterol sulfate

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol sulfate
Generic Name albuterol sulfate
Labeler padagis israel pharmaceuticals ltd
Dosage Form AEROSOL, METERED
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate 90 ug/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-088
Product ID 45802-088_0ce1f4c5-3283-4e4d-a107-d82c8e78ee84
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203760
Listing Expiration 2026-12-31
Marketing Start 2020-02-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802088
Hyphenated Format 45802-088

Supplemental Identifiers

RxCUI
2123072
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 ANDA203760 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 90 ug/1
source: ndc
Packaging
  • 1 INHALER in 1 CARTON (45802-088-01) / 200 AEROSOL, METERED in 1 INHALER
source: ndc

Packages (1)

45802-088-01 1 INHALER in 1 CARTON (45802-088-01) / 200 AEROSOL, METERED in 1 INHALER

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": "0ce1f4c5-3283-4e4d-a107-d82c8e78ee84", "openfda": {"unii": ["021SEF3731"], "rxcui": ["2123072"], "spl_set_id": ["489201d2-9ed0-419b-81dc-a7f7f86b59ed"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INHALER in 1 CARTON (45802-088-01)  / 200 AEROSOL, METERED in 1 INHALER", "package_ndc": "45802-088-01", "marketing_start_date": "20200226"}], "brand_name": "albuterol sulfate", "product_id": "45802-088_0ce1f4c5-3283-4e4d-a107-d82c8e78ee84", "dosage_form": "AEROSOL, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "45802-088", "generic_name": "albuterol sulfate", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "albuterol sulfate", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "90 ug/1"}], "application_number": "ANDA203760", "marketing_category": "ANDA", "marketing_start_date": "20200226", "listing_expiration_date": "20261231"}