NDC Code(s) : 52125-743-45
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Levocarnitine Levocarnitine SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-743(NDC:64980-503)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levocarnitine(UNII: 0G389FZZ9M)
(LEVOCARNITINE - UNII:0G389FZZ9M) 		Levocarnitine1 g in 10 mL
Inactive Ingredients
Ingredient Name Strength
Malic Acid(UNII: 817L1N4CKP)
Methylparaben(UNII: A2I8C7HI9T)
Propylparaben(UNII: Z8IX2SC1OH)
Sucrose(UNII: C151H8M554)
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-743-45118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076851 11/29/2013

PRINCIPAL DISPLAY PANEL

DRUG: Levocarnitine


GENERIC: Levocarnitine


DOSAGE: SOLUTION


ADMINSTRATION: ORAL


NDC: 52125-743-45


ACTIVE INGREDIENT(S):

  • Levocarnitine 1g in 10mL


INACTIVE INGREDIENT(S):

  • Malic Acid
  • Methylparaben
  • Propylparaben
  • Sucrose
  • Water


PACKAGING: 118 mL in 1 BOTTLE, PLASTIC




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