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LIDOCAINE

LIDOCAINE

Approved
Approval ID

b8663046-67a4-4858-e053-2a95a90a8aed

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 1, 2021

Manufacturers
FDA

DIRECT RX

DUNS: 079254320

Products 3

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 Code72189-165
Application NumberANDA086724
Product Classification
M
Marketing Category
C73584
G
Generic Name
LIDOCAINE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 1, 2021
FDA Product Classification

INGREDIENTS (4)

POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
LIDOCAINEActive
Quantity: 50 mg in 1 g
Code: 98PI200987
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT

LIDOCAINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72189-211
Application NumberANDA086724
Product Classification
M
Marketing Category
C73584
G
Generic Name
LIDOCAINE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 1, 2021
FDA Product Classification

INGREDIENTS (4)

POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
LIDOCAINEActive
Quantity: 50 mg in 1 g
Code: 98PI200987
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

LIDOCAINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72189-168
Application NumberANDA207810
Product Classification
M
Marketing Category
C73584
G
Generic Name
LIDOCAINE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 1, 2021
FDA Product Classification

INGREDIENTS (3)

LIDOCAINEActive
Quantity: 50 mg in 1 g
Code: 98PI200987
Classification: ACTIB
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT

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LIDOCAINE - FDA Drug Approval Details