levalbuterol

Generic: levalbuterol

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levalbuterol
Generic Name levalbuterol
Labeler proficient rx lp
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

levalbuterol hydrochloride .63 mg/3mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-953
Product ID 63187-953_efb4df4c-19c2-4c42-bf10-d1613186db7b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090297
Listing Expiration 2026-12-31
Marketing Start 2013-04-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187953
Hyphenated Format 63187-953

Supplemental Identifiers

RxCUI
311286
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 (source: ndc)
Application Number ANDA090297 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .63 mg/3mL
source: ndc
Packaging
  • 24 VIAL, SINGLE-DOSE in 1 CARTON (63187-953-24) / 3 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

63187-953-24 24 VIAL, SINGLE-DOSE in 1 CARTON (63187-953-24) / 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": "efb4df4c-19c2-4c42-bf10-d1613186db7b", "openfda": {"unii": ["WDQ1526QJM"], "rxcui": ["311286"], "spl_set_id": ["97699821-81f8-4623-8504-e479c0f4b183"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "24 VIAL, SINGLE-DOSE in 1 CARTON (63187-953-24)  / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63187-953-24", "marketing_start_date": "20180101"}], "brand_name": "Levalbuterol", "product_id": "63187-953_efb4df4c-19c2-4c42-bf10-d1613186db7b", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "63187-953", "generic_name": "Levalbuterol", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levalbuterol", "active_ingredients": [{"name": "LEVALBUTEROL HYDROCHLORIDE", "strength": ".63 mg/3mL"}], "application_number": "ANDA090297", "marketing_category": "ANDA", "marketing_start_date": "20130429", "listing_expiration_date": "20261231"}