NDC 60846-701-35
API & Excipient Details

Lidocaine marketed by Gemini Laboratories, Inc. under NDC Code 60846-701-35

NDC Code(s) : 60846-701-35, 60846-701-50
Packager : Gemini Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LidocaineLidocaine OINTMENT

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:60846-701
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE(UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1450(UNII: OJ4Z5Z32L4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60846-701-35	35.44 g in 1 TUBE Type 0: Not a Combination Product	03/11/2016
2	NDC:60846-701-50	50 g in 1 JAR Type 0: Not a Combination Product	03/11/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206297	03/11/2016	11/30/2018

PRINCIPAL DISPLAY PANEL

label 1

label 1

label 1