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Xylocaine

Xylocaine 1% (10mg/mL)

Approved
Approval ID

1a28f8fe-7334-452a-b8f7-99c9c1eca953

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 26, 2011

Manufacturers
FDA

General Injectables & Vaccines, Inc

DUNS: 108250663

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 Code52584-485
Application NumberNDA006488
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateSeptember 26, 2011
FDA Product Classification

INGREDIENTS (1)

Lidocaine HydrochlorideActive
Quantity: 10 mg in 1 mL
Code: V13007Z41A
Classification: ACTIB

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Xylocaine - FDA Drug Approval Details