MedPath

Lidocaine

Lidocaine Hydrochloride Injection, USP

Approved
Approval ID

a40610ac-b8d6-4a75-aeb6-fbea90371b74

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 5, 2022

Manufacturers
FDA

Fresenius Kabi USA, LLC

DUNS: 608775388

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 Code63323-201
Application NumberANDA080404
Marketing CategoryC73584
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateAugust 5, 2022
Generic NameLIDOCAINE HYDROCHLORIDE

INGREDIENTS (5)

HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT

LIDOCAINE HYDROCHLORIDE

PRODUCT DETAILS

NDC Product Code63323-202
Application NumberANDA080404
Marketing CategoryC73584
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateAugust 5, 2022
Generic NameLIDOCAINE HYDROCHLORIDE

INGREDIENTS (5)

METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
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Lidocaine - FDA Approval | MedPath