Anestacon
Lidocaine Hydrochloride Jelly USP, 2%(Anestacon)
Approved
Approval ID
d5e51288-32ec-4d54-b152-7981cac9da9a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2014
Manufacturers
FDA
Hi-Tech Pharmacal Co., Inc.
DUNS: 101196749
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50383-772
Application NumberANDA080429
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 29, 2014
FDA Product Classification
INGREDIENTS (7)
Lidocaine hydrochlorideActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT
Sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT