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Lidocaine Hydrochloride

LIDOCAINEHYDROCHLORIDEINJECTION, USP

Approved
Approval ID

ad1ef0a8-88db-4648-c098-d009eaeb4e5b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 29, 2020

Manufacturers
FDA

Hospira, Inc.

DUNS: 141588017

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 Code0409-4903
Application NumberANDA083158
Product Classification
M
Marketing Category
C73584
G
Generic Name
LIDOCAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 29, 2020
FDA Product Classification

INGREDIENTS (4)

LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
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 Code0409-9137
Application NumberANDA040302
Product Classification
M
Marketing Category
C73584
G
Generic Name
LIDOCAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 29, 2020
FDA Product Classification

INGREDIENTS (4)

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

LIDOCAINE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0409-1323
Application NumberANDA040302
Product Classification
M
Marketing Category
C73584
G
Generic Name
LIDOCAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 29, 2020
FDA Product Classification

INGREDIENTS (4)

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

LIDOCAINE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0409-4904
Application NumberANDA083158
Product Classification
M
Marketing Category
C73584
G
Generic Name
LIDOCAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 29, 2020
FDA Product Classification

INGREDIENTS (4)

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

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Lidocaine Hydrochloride - FDA Drug Approval Details