Lidocaine and Prilocaine
LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
Approved
Approval ID
b61c6a09-7764-4a92-93a9-a1356aeeaa9c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine and Prilocaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-388
Application NumberANDA076453
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine and Prilocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 15, 2009
FDA Product Classification
INGREDIENTS (4)
lidocaineActive
Quantity: 25 mg in 1 g
Code: 98PI200987
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
prilocaineActive
Quantity: 25 mg in 1 g
Code: 046O35D44R
Classification: ACTIB
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT