levalbuterol

Generic: levalbuterol

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

Drug Facts

Product Profile

Brand Name levalbuterol
Generic Name levalbuterol
Labeler mylan pharmaceuticals inc.
Dosage Form SOLUTION, CONCENTRATE
Routes
RESPIRATORY (INHALATION)
Active Ingredients

levalbuterol hydrochloride 1.25 mg/.5mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-6993
Product ID 0378-6993_0aa39730-fc51-4088-8955-b11aac3025d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078309
Listing Expiration 2026-12-31
Marketing Start 2009-08-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03786993
Hyphenated Format 0378-6993

Supplemental Identifiers

RxCUI
1855389
UNII
WDQ1526QJM

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 (source: ndc)
Generic Name levalbuterol (source: ndc)
Application Number ANDA078309 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 1.25 mg/.5mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (0378-6993-93) / 1 VIAL in 1 POUCH (0378-6993-31) / .5 mL in 1 VIAL
source: ndc

Packages (1)

0378-6993-93 30 POUCH in 1 CARTON (0378-6993-93) / 1 VIAL in 1 POUCH (0378-6993-31) / .5 mL in 1 VIAL

Ingredients (1)

levalbuterol hydrochloride (1.25 mg/.5mL)

Linked Drug Pages (1)

Levalbuterol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "0aa39730-fc51-4088-8955-b11aac3025d0", "openfda": {"unii": ["WDQ1526QJM"], "rxcui": ["1855389"], "spl_set_id": ["206bbdec-04f0-40e3-a259-32fc6bce20d8"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (0378-6993-93)  / 1 VIAL in 1 POUCH (0378-6993-31)  / .5 mL in 1 VIAL", "package_ndc": "0378-6993-93", "marketing_start_date": "20090828"}], "brand_name": "Levalbuterol", "product_id": "0378-6993_0aa39730-fc51-4088-8955-b11aac3025d0", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0378-6993", "generic_name": "levalbuterol", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levalbuterol", "active_ingredients": [{"name": "LEVALBUTEROL HYDROCHLORIDE", "strength": "1.25 mg/.5mL"}], "application_number": "ANDA078309", "marketing_category": "ANDA", "marketing_start_date": "20090828", "listing_expiration_date": "20261231"}