MedPath

LIDODERM

LIDODERM® (Lidocaine Patch 5%)

Approved
Approval ID

7ab30afe-4de2-4fe5-9e62-a484683fb93f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 21, 2011

Manufacturers
FDA

STAT RX USA LLC

DUNS: 786036330

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 Code16590-141
Application NumberNDA020612
Product Classification
M
Marketing Category
C73594
G
Generic Name
LIDOCAINE
Product Specifications
Route of AdministrationCUTANEOUS
Effective DateJuly 21, 2011
FDA Product Classification

INGREDIENTS (11)

LIDOCAINEActive
Quantity: 700 mg in 1 1
Code: 98PI200987
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
UREAInactive
Code: 8W8T17847W
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT

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LIDODERM - FDA Drug Approval Details