NDC Code(s) : 52125-447-20
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Levothyroxine Sodiumlevothyroxine sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-447(NDC:0378-1800)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM(UNII: 9J765S329G)
(LEVOTHYROXINE - UNII:Q51BO43MG4) 		LEVOTHYROXINE25 ug
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
POVIDONE(UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SUCROSE(UNII: C151H8M554)
CROSPOVIDONE(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
Product Characteristics
Color orange Score 2 pieces
Shape OVAL Size 9 mm
Flavor Imprint Code M;L;4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-447-20100 in 1 VIAL Type 0: Not a Combination Product13/08/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076187 08/13/2013 08/13/2014

PRINCIPAL DISPLAY PANEL

DRUG: Levothyroxine Sodium


GENERIC: levothyroxine sodium


DOSAGE: TABLET


ADMINSTRATION: ORAL


NDC: 52125-447-20


ACTIVE INGREDIENT(S):

  • LEVOTHYROXINE SODIUM 25ug in 1


INACTIVE INGREDIENT(S):

  • BUTYLATED HYDROXYANISOLE
  • POVIDONE
  • CELLULOSE, MICROCRYSTALLINE
  • SODIUM LAURYL SULFATE
  • SUCROSE
  • CROSPOVIDONE
  • SILICON DIOXIDE
  • FD&C YELLOW NO. 6
  • MAGNESIUM STEARATE
  • MANNITOL


COLOR: orange


SHAPE: CAPSULE


SCORE: Two even pieces


SIZE: 9 mm


IMPRINT: M;L;4


PACKAGING: 100 in 1 VIAL



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