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
Routes
RESPIRATORY (INHALATION)
Active Ingredients

levalbuterol hydrochloride .31 mg/3mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-943
Product ID 65862-943_29ed39d7-180a-93e4-e063-6294a90a73a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207625
Listing Expiration 2026-12-31
Marketing Start 2016-12-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862943
Hyphenated Format 65862-943

Supplemental Identifiers

RxCUI
242754 311286 349590
UPC
0365862943057 0365862943255 0365862944252 0365862945051 0365862944054 0365862945259
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 ANDA207625 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .31 mg/3mL
source: ndc
Packaging
  • 5 POUCH in 1 CARTON (65862-943-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-943-05) / 3 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

65862-943-25 5 POUCH in 1 CARTON (65862-943-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-943-05) / 3 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

levalbuterol hydrochloride (.31 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": "29ed39d7-180a-93e4-e063-6294a90a73a9", "openfda": {"upc": ["0365862943057", "0365862943255", "0365862944252", "0365862945051", "0365862944054", "0365862945259"], "unii": ["WDQ1526QJM"], "rxcui": ["242754", "311286", "349590"], "spl_set_id": ["5f1c4f22-d420-495c-8f64-33532638215f"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (65862-943-25)  / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-943-05)  / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65862-943-25", "marketing_start_date": "20161230"}], "brand_name": "Levalbuterol", "product_id": "65862-943_29ed39d7-180a-93e4-e063-6294a90a73a9", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "65862-943", "generic_name": "Levalbuterol", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levalbuterol", "active_ingredients": [{"name": "LEVALBUTEROL HYDROCHLORIDE", "strength": ".31 mg/3mL"}], "application_number": "ANDA207625", "marketing_category": "ANDA", "marketing_start_date": "20161230", "listing_expiration_date": "20261231"}