levalbuterol

Generic: levalbuterol hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levalbuterol
Generic Name levalbuterol hydrochloride
Labeler bryant ranch prepack
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

levalbuterol hydrochloride 1.25 mg/3mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2083
Product ID 72162-2083_09dcc8a8-2973-42a3-b0da-0ab1ffdbb959
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203653
Listing Expiration 2026-12-31
Marketing Start 2016-03-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 721622083
Hyphenated Format 72162-2083

Supplemental Identifiers

RxCUI
242754
UNII
WDQ1526QJM

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
  • 1.25 mg/3mL
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (72162-2083-2) / 25 AMPULE in 1 POUCH / 3 mL in 1 AMPULE
source: ndc

Packages (1)

72162-2083-2 1 POUCH in 1 CARTON (72162-2083-2) / 25 AMPULE in 1 POUCH / 3 mL in 1 AMPULE

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": "09dcc8a8-2973-42a3-b0da-0ab1ffdbb959", "openfda": {"unii": ["WDQ1526QJM"], "rxcui": ["242754"], "spl_set_id": ["e7e3d858-6a0d-482c-b71b-de90d3ef3169"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (72162-2083-2)  / 25 AMPULE in 1 POUCH / 3 mL in 1 AMPULE", "package_ndc": "72162-2083-2", "marketing_start_date": "20230914"}], "brand_name": "Levalbuterol", "product_id": "72162-2083_09dcc8a8-2973-42a3-b0da-0ab1ffdbb959", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "72162-2083", "generic_name": "Levalbuterol Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levalbuterol", "active_ingredients": [{"name": "LEVALBUTEROL HYDROCHLORIDE", "strength": "1.25 mg/3mL"}], "application_number": "ANDA203653", "marketing_category": "ANDA", "marketing_start_date": "20160322", "listing_expiration_date": "20261231"}