levalbuterol

Generic: levalbuterol

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levalbuterol
Generic Name levalbuterol
Labeler aurobindo pharma limited
Dosage Form SOLUTION, CONCENTRATE
Routes
RESPIRATORY (INHALATION)
Active Ingredients

levalbuterol hydrochloride 1.25 mg/.5mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-942
Product ID 65862-942_08fe55b3-a3cd-d8cf-e063-6394a90a1a95
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207628
Listing Expiration 2026-12-31
Marketing Start 2017-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862942
Hyphenated Format 65862-942

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 ANDA207628 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 1.25 mg/.5mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (65862-942-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-942-50) / .5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

65862-942-03 30 POUCH in 1 CARTON (65862-942-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-942-50) / .5 mL in 1 VIAL, SINGLE-DOSE

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": "08fe55b3-a3cd-d8cf-e063-6394a90a1a95", "openfda": {"unii": ["WDQ1526QJM"], "rxcui": ["1855389"], "spl_set_id": ["e1a9effb-6ef7-4651-b0ef-a9265600caff"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (65862-942-03)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-942-50)  / .5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65862-942-03", "marketing_start_date": "20170131"}], "brand_name": "LEVALBUTEROL", "product_id": "65862-942_08fe55b3-a3cd-d8cf-e063-6394a90a1a95", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "65862-942", "generic_name": "LEVALBUTEROL", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVALBUTEROL", "active_ingredients": [{"name": "LEVALBUTEROL HYDROCHLORIDE", "strength": "1.25 mg/.5mL"}], "application_number": "ANDA207628", "marketing_category": "ANDA", "marketing_start_date": "20170131", "listing_expiration_date": "20261231"}