NDC Code(s) : 52125-414-01
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Novolin70/30 Human Insulin INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-414(NDC:0169-1837)
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN HUMAN(UNII: 1Y17CTI5SR)
(INSULIN HUMAN - UNII:1Y17CTI5SR) 		INSULIN HUMAN100 [USP'U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ZINC CHLORIDE(UNII: 86Q357L16B)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)
METACRESOL(UNII: GGO4Y809LO)
PHENOL(UNII: 339NCG44TV)
PROTAMINE SULFATE(UNII: 0DE9724IHC)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-414-0110 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019991 06/13/2013

PRINCIPAL DISPLAY PANEL

DRUG: Novolin70/30 70/30


GENERIC: Human Insulin


DOSAGE: INJECTION, SUSPENSION


ADMINSTRATION: SUBCUTANEOUS


NDC: 52125-414-01


ACTIVE INGREDIENT(S):

  • INSULIN HUMAN 100[USP'U] in 1mL


INACTIVE INGREDIENT(S):

  • GLYCERIN
  • HYDROCHLORIC ACID
  • SODIUM HYDROXIDE
  • ZINC CHLORIDE
  • SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
  • METACRESOL
  • PHENOL
  • PROTAMINE SULFATE
  • WATER


PACKAGING: 10 mL in 1 VIAL



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