NDC Code(s) : 52125-415-01
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Humulin 70/30 Insulin human INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-415(NDC:0002-8715)
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 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin(UNII: PDC6A3C0OX)
Water(UNII: 059QF0KO0R)
Hydrochloric acid(UNII: QTT17582CB)
Sodium Phosphate, Dibasic(UNII: GR686LBA74)
Protamine sulfate(UNII: 0DE9724IHC)
Metacresol(UNII: GGO4Y809LO)
Phenol(UNII: 339NCG44TV)
Sodium hydroxide(UNII: 55X04QC32I)
Zinc(UNII: J41CSQ7QDS)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-415-0110 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019717 06/12/2013

PRINCIPAL DISPLAY PANEL

DRUG: Humulin 70/30 70/30


GENERIC: Insulin human


DOSAGE: INJECTION, SUSPENSION


ADMINSTRATION: SUBCUTANEOUS


NDC: 52125-415-01


ACTIVE INGREDIENT(S):

  • Insulin human 100[iU] in 1mL


INACTIVE INGREDIENT(S):

  • Glycerin
  • Water
  • Hydrochloric acid
  • Sodium Phosphate, Dibasic
  • Protamine sulfate
  • Metacresol
  • Phenol
  • Sodium hydroxide
  • Zinc


PACKAGING: 10 mL in 1 VIAL



/xml/541b0299-7625-4598-8826-8b6d50a96397/MM2.jpg

/xml/541b0299-7625-4598-8826-8b6d50a96397/MM2.jpg

/>