levalbuterol

Generic: levalbuterol

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

Drug Facts

Product Profile

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

levalbuterol hydrochloride 1.25 mg/3mL

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-4148
Product ID 0093-4148_c4bbe9ea-2824-4b67-8557-830bbb80ba5d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090297
Listing Expiration 2026-12-31
Marketing Start 2013-04-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00934148
Hyphenated Format 0093-4148

Supplemental Identifiers

RxCUI
242754 311286 349590
UPC
0300934148565 0300934146561 0300934145564
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 ANDA090297 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 1.25 mg/3mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (0093-4148-56) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4148-45) / 3 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0093-4148-56 6 POUCH in 1 CARTON (0093-4148-56) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4148-45) / 3 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

levalbuterol hydrochloride (1.25 mg/3mL)

Linked Drug Pages (1)

Levalbuterol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "c4bbe9ea-2824-4b67-8557-830bbb80ba5d", "openfda": {"upc": ["0300934148565", "0300934146561", "0300934145564"], "unii": ["WDQ1526QJM"], "rxcui": ["242754", "311286", "349590"], "spl_set_id": ["f3ce78d9-e923-400e-b3cd-3e6124ac7f6d"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (0093-4148-56)  / 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4148-45)  / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0093-4148-56", "marketing_start_date": "20190107"}], "brand_name": "Levalbuterol", "product_id": "0093-4148_c4bbe9ea-2824-4b67-8557-830bbb80ba5d", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0093-4148", "generic_name": "Levalbuterol", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levalbuterol", "active_ingredients": [{"name": "LEVALBUTEROL HYDROCHLORIDE", "strength": "1.25 mg/3mL"}], "application_number": "ANDA090297", "marketing_category": "ANDA", "marketing_start_date": "20130429", "listing_expiration_date": "20261231"}