levalbuterol inhalation solution (47335-746)

Drug Facts

Product Profile

Brand Name levalbuterol inhalation solution

Generic Name levalbuterol inhalation solution

Labeler sun pharmaceutical industries, inc.

Dosage Form SOLUTION

Routes

RESPIRATORY (INHALATION)

Active Ingredients

levalbuterol hydrochloride .63 mg/3mL

Manufacturer

Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-746

Product ID 47335-746_f264b091-1414-4e44-abae-d0b787c94397

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207820

Listing Expiration 2026-12-31

Marketing Start 2018-12-01

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335746

Hyphenated Format 47335-746

Supplemental Identifiers

RxCUI

242754 311286 349590

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 inhalation solution (source: ndc)

Generic Name levalbuterol inhalation solution (source: ndc)

Application Number ANDA207820 (source: ndc)

Routes

RESPIRATORY (INHALATION)

source: ndc

Resolved Composition

Strengths

.63 mg/3mL

source: ndc

Packaging

5 POUCH in 1 CARTON (47335-746-01) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
2 POUCH in 1 CARTON (47335-746-49) / 12 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
6 POUCH in 1 CARTON (47335-746-52) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

source: ndc

Packages (3)

47335-746-01 5 POUCH in 1 CARTON (47335-746-01) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 47335-746-49 2 POUCH in 1 CARTON (47335-746-49) / 12 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 47335-746-52 6 POUCH in 1 CARTON (47335-746-52) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

levalbuterol hydrochloride (.63 mg/3mL)

Linked Drug Pages (1)

Levalbuterol Inhalation Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "f264b091-1414-4e44-abae-d0b787c94397", "openfda": {"unii": ["WDQ1526QJM"], "rxcui": ["242754", "311286", "349590"], "spl_set_id": ["85a59e0c-ff09-49a6-b7b8-616e033107b4"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (47335-746-01)  / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "47335-746-01", "marketing_start_date": "20200701"}, {"sample": false, "description": "2 POUCH in 1 CARTON (47335-746-49)  / 12 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "47335-746-49", "marketing_start_date": "20181201"}, {"sample": false, "description": "6 POUCH in 1 CARTON (47335-746-52)  / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "47335-746-52", "marketing_start_date": "20181201"}], "brand_name": "Levalbuterol Inhalation Solution", "product_id": "47335-746_f264b091-1414-4e44-abae-d0b787c94397", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "47335-746", "generic_name": "Levalbuterol Inhalation Solution", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levalbuterol Inhalation Solution", "active_ingredients": [{"name": "LEVALBUTEROL HYDROCHLORIDE", "strength": ".63 mg/3mL"}], "application_number": "ANDA207820", "marketing_category": "ANDA", "marketing_start_date": "20181201", "listing_expiration_date": "20261231"}