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Lidocaine Hydrochloride

LIDO CAINE HYDROCHLORIDE INJECTION, USP

Approved
Approval ID

1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 11, 2020

Manufacturers
FDA

Hikma Pharmaceuticals USA Inc.

DUNS: 001230762

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lidocaine Hydrochloride

PRODUCT DETAILS

NDC Product Code0143-9594
Application NumberANDA084625
Marketing CategoryC73584
Route of AdministrationEPIDURAL, INFILTRATION, INTRACAUDAL
Effective DateSeptember 17, 2018
Generic NameLidocaine Hydrochloride

INGREDIENTS (4)

LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
SODIUM CHLORIDEInactive
Quantity: 6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

LIDOCAINE HYDROCHLORIDE

PRODUCT DETAILS

NDC Product Code0143-9595
Application NumberANDA084625
Marketing CategoryC73584
Route of AdministrationEPIDURAL, INFILTRATION, INTRACAUDAL
Effective DateSeptember 17, 2018
Generic NameLIDOCAINE HYDROCHLORIDE

INGREDIENTS (4)

LIDOCAINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

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Lidocaine Hydrochloride - FDA Drug Approval Details