xopenex hfa

Generic: levalbuterol tartrate

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xopenex hfa
Generic Name levalbuterol tartrate
Labeler lupin pharmaceuticals, inc.
Dosage Form AEROSOL, METERED
Routes
ORAL
Active Ingredients

levalbuterol tartrate 45 ug/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 27437-056
Product ID 27437-056_905559df-c984-469d-b6b1-a38fdc320471
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021730
Listing Expiration 2026-12-31
Marketing Start 2023-11-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27437056
Hyphenated Format 27437-056

Supplemental Identifiers

RxCUI
745791 746466
UNII
ADS4I3E22M

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 xopenex hfa (source: ndc)
Generic Name levalbuterol tartrate (source: ndc)
Application Number NDA021730 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 45 ug/1
source: ndc
Packaging
  • 1 INHALER in 1 CARTON (27437-056-01) / 200 AEROSOL, METERED in 1 INHALER
source: ndc

Packages (1)

27437-056-01 1 INHALER in 1 CARTON (27437-056-01) / 200 AEROSOL, METERED in 1 INHALER

Ingredients (1)

levalbuterol tartrate (45 ug/1)

Linked Drug Pages (1)

XOPENEX HFA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "905559df-c984-469d-b6b1-a38fdc320471", "openfda": {"unii": ["ADS4I3E22M"], "rxcui": ["745791", "746466"], "spl_set_id": ["70a35706-d7a8-4a48-98c6-1cab1c42fe8d"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INHALER in 1 CARTON (27437-056-01)  / 200 AEROSOL, METERED in 1 INHALER", "package_ndc": "27437-056-01", "marketing_start_date": "20231110"}], "brand_name": "XOPENEX HFA", "product_id": "27437-056_905559df-c984-469d-b6b1-a38fdc320471", "dosage_form": "AEROSOL, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "27437-056", "generic_name": "levalbuterol tartrate", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XOPENEX HFA", "active_ingredients": [{"name": "LEVALBUTEROL TARTRATE", "strength": "45 ug/1"}], "application_number": "NDA021730", "marketing_category": "NDA", "marketing_start_date": "20231110", "listing_expiration_date": "20261231"}