levalbuterol

Generic: levalbuterol hydrochloride

Labeler: burel pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levalbuterol
Generic Name levalbuterol hydrochloride
Labeler burel pharmaceuticals, llc
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

levalbuterol hydrochloride .63 mg/3mL

Manufacturer
Burel Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 35573-444
Product ID 35573-444_0639bb69-d41d-4786-af70-797c452fbbfb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203653
Listing Expiration 2026-12-31
Marketing Start 2021-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 35573444
Hyphenated Format 35573-444

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 (source: ndc)
Generic Name levalbuterol hydrochloride (source: ndc)
Application Number ANDA203653 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .63 mg/3mL
source: ndc
Packaging
  • 25 POUCH in 1 CARTON (35573-444-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

35573-444-25 25 POUCH in 1 CARTON (35573-444-25) / 25 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 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "0639bb69-d41d-4786-af70-797c452fbbfb", "openfda": {"unii": ["WDQ1526QJM"], "rxcui": ["242754", "311286", "349590"], "spl_set_id": ["737fe40b-798b-4d7f-bec9-7af952018ab5"], "manufacturer_name": ["Burel Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 POUCH in 1 CARTON (35573-444-25)  / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "35573-444-25", "marketing_start_date": "20210401"}], "brand_name": "Levalbuterol", "product_id": "35573-444_0639bb69-d41d-4786-af70-797c452fbbfb", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "35573-444", "generic_name": "Levalbuterol Hydrochloride", "labeler_name": "Burel Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levalbuterol", "active_ingredients": [{"name": "LEVALBUTEROL HYDROCHLORIDE", "strength": ".63 mg/3mL"}], "application_number": "ANDA203653", "marketing_category": "ANDA", "marketing_start_date": "20210401", "listing_expiration_date": "20261231"}