levalbuterol tartrate hfa inhalation

Generic: levalbuterol tartrate

Labeler: praxis, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name levalbuterol tartrate hfa inhalation
Generic Name levalbuterol tartrate
Labeler praxis, llc
Dosage Form AEROSOL, METERED
Routes
ORAL
Active Ingredients

levalbuterol tartrate 45 ug/1

Manufacturer
Praxis, LLC

Identifiers & Regulatory

Product NDC 59368-410
Product ID 59368-410_37c9bb3a-2206-194d-e063-6394a90a145c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021730
Listing Expiration 2026-12-31
Marketing Start 2016-10-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59368410
Hyphenated Format 59368-410

Supplemental Identifiers

RxCUI
745791
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 levalbuterol tartrate hfa inhalation (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 (59368-410-01) / 200 AEROSOL, METERED in 1 INHALER
source: ndc

Packages (1)

59368-410-01 1 INHALER in 1 CARTON (59368-410-01) / 200 AEROSOL, METERED in 1 INHALER

Ingredients (1)

levalbuterol tartrate (45 ug/1)

Linked Drug Pages (1)

Levalbuterol tartrate HFA inhalation ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "37c9bb3a-2206-194d-e063-6394a90a145c", "openfda": {"unii": ["ADS4I3E22M"], "rxcui": ["745791"], "spl_set_id": ["37c9c12a-db54-1fd6-e063-6394a90afb92"], "manufacturer_name": ["Praxis, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INHALER in 1 CARTON (59368-410-01)  / 200 AEROSOL, METERED in 1 INHALER", "package_ndc": "59368-410-01", "marketing_start_date": "20161003"}], "brand_name": "Levalbuterol tartrate HFA inhalation", "product_id": "59368-410_37c9bb3a-2206-194d-e063-6394a90a145c", "dosage_form": "AEROSOL, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "59368-410", "generic_name": "levalbuterol tartrate", "labeler_name": "Praxis, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levalbuterol tartrate HFA inhalation", "active_ingredients": [{"name": "LEVALBUTEROL TARTRATE", "strength": "45 ug/1"}], "application_number": "NDA021730", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20161003", "listing_expiration_date": "20261231"}