levalbuterol

Generic: levalbuterol

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levalbuterol
Generic Name levalbuterol
Labeler mylan pharmaceuticals inc.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

levalbuterol hydrochloride 1.25 mg/3mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-9692
Product ID 0378-9692_2f82efe7-5a39-44e6-a7c0-840a60c6246f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203653
Listing Expiration 2026-12-31
Marketing Start 2018-09-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03789692
Hyphenated Format 0378-9692

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 (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 (0378-9692-52) / 25 AMPULE in 1 POUCH (0378-9692-62) / 3 mL in 1 AMPULE
source: ndc

Packages (1)

0378-9692-52 1 POUCH in 1 CARTON (0378-9692-52) / 25 AMPULE in 1 POUCH (0378-9692-62) / 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": "2f82efe7-5a39-44e6-a7c0-840a60c6246f", "openfda": {"unii": ["WDQ1526QJM"], "rxcui": ["242754", "311286", "349590"], "spl_set_id": ["5b4fa89e-aa46-4504-a275-246f3b4df1df"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (0378-9692-52)  / 25 AMPULE in 1 POUCH (0378-9692-62)  / 3 mL in 1 AMPULE", "package_ndc": "0378-9692-52", "marketing_start_date": "20180910"}], "brand_name": "Levalbuterol", "product_id": "0378-9692_2f82efe7-5a39-44e6-a7c0-840a60c6246f", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0378-9692", "generic_name": "Levalbuterol", "labeler_name": "Mylan Pharmaceuticals Inc.", "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": "20180910", "listing_expiration_date": "20261231"}