albuterol sulfate

Generic: albuterol sulfate

Labeler: exelan pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol sulfate
Generic Name albuterol sulfate
Labeler exelan pharmaceuticals, inc.
Dosage Form INHALANT
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate 90 ug/1

Manufacturer
Exelan Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 76282-679
Product ID 76282-679_3449ab68-28d3-42f5-8d34-329bf6fa0e6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209959
Listing Expiration 2026-12-31
Marketing Start 2021-10-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282679
Hyphenated Format 76282-679

Supplemental Identifiers

RxCUI
2123111
UPC
0376282679426
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 ANDA209959 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 90 ug/1
source: ndc
Packaging
  • 1 CANISTER in 1 CARTON (76282-679-42) / 200 INHALANT in 1 CANISTER
source: ndc

Packages (1)

76282-679-42 1 CANISTER in 1 CARTON (76282-679-42) / 200 INHALANT 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": "3449ab68-28d3-42f5-8d34-329bf6fa0e6b", "openfda": {"upc": ["0376282679426"], "unii": ["021SEF3731"], "rxcui": ["2123111"], "spl_set_id": ["29e35e54-dbd6-4426-993f-893d7a4d69be"], "manufacturer_name": ["Exelan Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CANISTER in 1 CARTON (76282-679-42)  / 200 INHALANT in 1 CANISTER", "package_ndc": "76282-679-42", "marketing_start_date": "20211004"}], "brand_name": "ALBUTEROL SULFATE", "product_id": "76282-679_3449ab68-28d3-42f5-8d34-329bf6fa0e6b", "dosage_form": "INHALANT", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "76282-679", "generic_name": "albuterol sulfate", "labeler_name": "Exelan Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ALBUTEROL SULFATE", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "90 ug/1"}], "application_number": "ANDA209959", "marketing_category": "ANDA", "marketing_start_date": "20211004", "listing_expiration_date": "20261231"}