Xylocaine
Xylocaine
Approved
Approval ID
441a0cfa-a5fc-4ace-8dd8-84bb8c804c2e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
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 Code54868-1798
Application NumberNDA006488
Product Classification
M
Marketing Category
C73594
G
Generic Name
LIDOCAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateFebruary 9, 2012
FDA Product Classification
INGREDIENTS (5)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LIDOCAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1796
Application NumberNDA006488
Product Classification
M
Marketing Category
C73594
G
Generic Name
LIDOCAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateFebruary 9, 2012
FDA Product Classification
INGREDIENTS (8)
LIDOCAINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V13007Z41A
Classification: ACTIB
EPINEPHRINE BITARTRATEActive
Quantity: 0.01 mg in 1 mL
Code: 30Q7KI53AK
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.2 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 0.5 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
LIDOCAINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1795
Application NumberNDA006488
Product Classification
M
Marketing Category
C73594
G
Generic Name
LIDOCAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateFebruary 9, 2012
FDA Product Classification
INGREDIENTS (5)
LIDOCAINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V13007Z41A
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT