NDC Code(s) : 61786-951-02
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:61786-951(NDC:43547-222)
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONES(UNII: FZ989GH94E)
TALC(UNII: 7SEV7J4R1U)
D&C RED NO. 27(UNII: 2LRS185U6K)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL 800(UNII: UH6KR4953D)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color pink Score 2 pieces
Shape OVAL Size 18 mm
Flavor Imprint Code SLC;222
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-951-0230 in 1 BLISTER PACK Type 0: Not a Combination Product24/10/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078106 10/24/2016

PRINCIPAL DISPLAY PANEL

DRUG: Levetiracetam

GENERIC: Levetiracetam

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 61786-951-02

COLOR: pink

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 18 mm

IMPRINT: SLC;222

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • LEVETIRACETAM 500mg in 1

INACTIVE INGREDIENT(S):

  • FD&C RED NO. 40
  • HYPROMELLOSE 2910 (6 MPA.S)
  • HYPROMELLOSE 2910 (3 MPA.S)
  • HYPROMELLOSE 2910 (50 MPA.S)
  • FD&C YELLOW NO. 6
  • TITANIUM DIOXIDE
  • POLYDEXTROSE
  • POLYETHYLENE GLYCOL 800
  • MAGNESIUM STEARATE
  • POVIDONES
  • SILICON DIOXIDE
  • STARCH, CORN
  • D&C RED NO. 27
  • FD&C BLUE NO. 2
  • TALC
  • TRIACETIN

/xml/117b5b9c-03a6-487e-a175-47d704f0ec38/Remedy_Label.jpg