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Lidocaine Hydrochloride

Lidocaine Hydrochloride Injection, USPFor Infiltration and Nerve Block

Approved
Approval ID

5d3e9984-cef9-46f2-a6c9-3be8b26f45b3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 29, 2022

Manufacturers
FDA

International Medication Systems, Limited

DUNS: 055750020

Products 1

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 Code76329-3390
Application NumberANDA083173
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 29, 2022
FDA Product Classification

INGREDIENTS (3)

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

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Lidocaine Hydrochloride - FDA Drug Approval Details