Lidocaine Hydrochloride
LIDOCAINE HYDROCHLORIDE JELLY USP, 2%A STERILE, WATER-SOLUBLE, TOPICAL ANESTHETIC
Approved
Approval ID
0cbc37d3-c2d6-4747-9834-7c23b38fcc20
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 3, 2021
Manufacturers
FDA
International Medication Systems, Limited
DUNS: 055750020
Products 4
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 Code76329-3011
Application NumberANDA086283
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 29, 2016
FDA Product Classification
INGREDIENTS (1)
LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
Lidocaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76329-3012
Application NumberANDA086283
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 29, 2016
FDA Product Classification
INGREDIENTS (1)
LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
Lidocaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76329-3015
Application NumberANDA086283
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 29, 2016
FDA Product Classification
INGREDIENTS (1)
LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
Lidocaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76329-3013
Application NumberANDA086283
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 29, 2016
FDA Product Classification
INGREDIENTS (1)
LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR