NDC Code(s) : 52125-416-01
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lantusinsulin glargine INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-416(NDC:0088-2220)
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN GLARGINE(UNII: 2ZM8CX04RZ)
(INSULIN GLARGINE - UNII:2ZM8CX04RZ) 		INSULIN GLARGINE100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID(UNII: QTT17582CB)
POLYSORBATE 20(UNII: 7T1F30V5YH)
WATER(UNII: 059QF0KO0R)
METACRESOL(UNII: GGO4Y809LO)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ZINC(UNII: J41CSQ7QDS)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-416-0110 mL in 1 VIAL, GLASS Type 0: Not a Combination Product08/01/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021081 01/08/2013 06/19/2015

PRINCIPAL DISPLAY PANEL

DRUG: Lantus


GENERIC: insulin glargine


DOSAGE: INJECTION, SOLUTION


ADMINSTRATION: SUBCUTANEOUS


NDC: 52125-416-01


ACTIVE INGREDIENT(S):

  • insulin glargine 100[iU] in 1mL


INACTIVE INGREDIENT(S):

  • hydrochloric acid
  • polysorbate 20
  • water
  • METACRESOL
  • sodium hydroxide
  • zinc


PACKAGING: 10 mL in 1 VIAL, GLASS



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