GLYDO- lidocaine hydrochloride jelly
Approved
Approval ID
3364b25d-bf30-c028-e063-6394a90a8008
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 22, 2025
Manufacturers
FDA
HF Acquisition Co. LLC, DBA HealthFirst
DUNS: 045657305
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
GLYDO- lidocaine hydrochloride jelly
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51662-1652
Application NumberANDA201094
Product Classification
M
Marketing Category
C73584
G
Generic Name
GLYDO- lidocaine hydrochloride jelly
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 22, 2025
FDA Product Classification
INGREDIENTS (3)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LIDOCAINE HYDROCHLORIDE ANHYDROUSActive
Quantity: 20 mg in 1 mL
Code: EC2CNF7XFP
Classification: ACTIB