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XYLOCAINE

Xylocaine®(lidocaine HCl Injection, USP)Xylocaine®(lidocaine HCl and epinephrine Injection, USP)For Infiltration and Nerve Block

Approved
Approval ID

57964c72-5ffe-4548-bca0-a5b0ca57ecb1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 22, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

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 Code21695-466
Application NumberNDA006488
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationINFILTRATION
Effective DateJanuary 25, 2007
FDA Product Classification

INGREDIENTS (4)

Lidocaine HydrochlorideActive
Quantity: 10 mg in 1 mL
Code: V13007Z41A
Classification: ACTIB
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium chlorideInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT

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XYLOCAINE - FDA Drug Approval Details