NDC Code(s) : 49349-779-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LevetiracetamLevetiracetam TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-779(NDC:68180-113)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM(UNII: 44YRR34555)
(LEVETIRACETAM - UNII:44YRR34555) 		LEVETIRACETAM500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSPOVIDONE(UNII: 68401960MK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color yellow (Yellow) Score 2 pieces
Shape OVAL (Oblong-shaped, Biconvex, Film-Coated) Size 18 mm
Flavor Imprint Code L;U;X02
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-779-0230 in 1 BLISTER PACK Type 0: Not a Combination Product28/09/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078154 09/28/2011

PRINCIPAL DISPLAY PANEL

DRUG: Levetiracetam

GENERIC: Levetiracetam

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 49349-779-02

COLOR: yellow

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 18 mm

IMPRINT: L;U;X02

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • LEVETIRACETAM 500mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • POVIDONE
  • SILICON DIOXIDE
  • POLYVINYL ALCOHOL, UNSPECIFIED
  • STARCH, CORN
  • TALC
  • POLYETHYLENE GLYCOL 4000
  • CROSPOVIDONE
  • FERRIC OXIDE YELLOW
  • HYPROMELLOSE 2910 (3 MPA.S)
  • HYPROMELLOSE 2910 (6 MPA.S)
  • MAGNESIUM STEARATE
  • TITANIUM DIOXIDE

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