albuterol sulfate

Generic: albuterol sulfate

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

albuterol sulfate 90 ug/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3541
Product ID 70518-3541_4456f00c-cd52-1daf-e063-6394a90abb35
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209954
Listing Expiration 2026-12-31
Marketing Start 2022-09-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183541
Hyphenated Format 70518-3541

Supplemental Identifiers

RxCUI
2123072
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 ANDA209954 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 90 ug/1
source: ndc
Packaging
  • 1 CANISTER in 1 CARTON (70518-3541-0) / 200 AEROSOL, METERED in 1 CANISTER
source: ndc

Packages (1)

70518-3541-0 1 CANISTER in 1 CARTON (70518-3541-0) / 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": "4456f00c-cd52-1daf-e063-6394a90abb35", "openfda": {"unii": ["021SEF3731"], "rxcui": ["2123072"], "spl_set_id": ["0cfb6c5d-eac2-4a1c-8a0f-6b00e819adda"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "1 CANISTER in 1 CARTON (70518-3541-0)  / 200 AEROSOL, METERED in 1 CANISTER", "package_ndc": "70518-3541-0", "marketing_start_date": "20220928"}], "brand_name": "Albuterol sulfate", "product_id": "70518-3541_4456f00c-cd52-1daf-e063-6394a90abb35", "dosage_form": "AEROSOL, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "70518-3541", "generic_name": "Albuterol sulfate", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol sulfate", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "90 ug/1"}], "application_number": "ANDA209954", "marketing_category": "ANDA", "marketing_start_date": "20220928", "listing_expiration_date": "20261231"}