Polocaine
POLOCAINE® (Mepivacaine Hydrochloride Injection, USP) POLOCAINE®-MPF (Mepivacaine Hydrochloride Injection, USP)
Approved
Approval ID
a27d0815-ae6b-4a21-a8f5-564c01e83814
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2022
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MEPIVACAINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-260
Application NumberANDA089406
Product Classification
M
Marketing Category
C73584
G
Generic Name
MEPIVACAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION
Effective DateAugust 12, 2019
FDA Product Classification
INGREDIENTS (6)
POTASSIUM CHLORIDEInactive
Quantity: 0.3 mg in 1 mL
Code: 660YQ98I10
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 6.6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CALCIUM CHLORIDEInactive
Quantity: 0.33 mg in 1 mL
Code: M4I0D6VV5M
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MEPIVACAINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 4VFX2L7EM5
Classification: ACTIB
MEPIVACAINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-294
Application NumberANDA089409
Product Classification
M
Marketing Category
C73584
G
Generic Name
MEPIVACAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION
Effective DateAugust 12, 2019
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Quantity: 4.6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
POTASSIUM CHLORIDEInactive
Quantity: 0.3 mg in 1 mL
Code: 660YQ98I10
Classification: IACT
MEPIVACAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: 4VFX2L7EM5
Classification: ACTIB
CALCIUM CHLORIDEInactive
Quantity: 0.33 mg in 1 mL
Code: M4I0D6VV5M
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MEPIVACAINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-283
Application NumberANDA089407
Product Classification
M
Marketing Category
C73584
G
Generic Name
MEPIVACAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINFILTRATION
Effective DateAugust 12, 2019
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MEPIVACAINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 4VFX2L7EM5
Classification: ACTIB
MEPIVACAINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-296
Application NumberANDA089410
Product Classification
M
Marketing Category
C73584
G
Generic Name
MEPIVACAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINFILTRATION
Effective DateAugust 12, 2019
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MEPIVACAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: 4VFX2L7EM5
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
MEPIVACAINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-293
Application NumberANDA089408
Product Classification
M
Marketing Category
C73584
G
Generic Name
MEPIVACAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION
Effective DateAugust 12, 2019
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Quantity: 5.6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POTASSIUM CHLORIDEInactive
Quantity: 0.3 mg in 1 mL
Code: 660YQ98I10
Classification: IACT
MEPIVACAINE HYDROCHLORIDEActive
Quantity: 15 mg in 1 mL
Code: 4VFX2L7EM5
Classification: ACTIB
CALCIUM CHLORIDEInactive
Quantity: 0.33 mg in 1 mL
Code: M4I0D6VV5M
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT