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Lidocaine

LIDOCAINE OINTMENT USP, 5%

Approved
Approval ID

7dc949d8-58cb-666b-e053-2a91aa0aba43

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 24, 2018

Manufacturers
FDA

medsource pharmaceuticals

DUNS: 833685915

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lidocaine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code45865-837
Application NumberANDA040911
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 24, 2018
FDA Product Classification

INGREDIENTS (4)

POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
LIDOCAINEActive
Quantity: 5 g in 100 g
Code: 98PI200987
Classification: ACTIB

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Lidocaine - FDA Drug Approval Details