NDC Code(s) : 69189-5187-1
Packager : Avera McKennan Hospital

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-5187(NDC:47335-187)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBIDOPA(UNII: MNX7R8C5VO)
(CARBIDOPA ANHYDROUS - UNII:KR87B45RGH) 		CARBIDOPA ANHYDROUS25 mg
LEVODOPA(UNII: 46627O600J)
(LEVODOPA - UNII:46627O600J) 		LEVODOPA100 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONES(UNII: FZ989GH94E)
MANNITOL(UNII: 3OWL53L36A)
CALCIUM SILICATE(UNII: S4255P4G5M)
CROSPOVIDONE(UNII: 2S7830E561)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
ASPARTAME(UNII: Z0H242BBR1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color YELLOW (light yellow) Score 2 pieces
Shape ROUND (Circular) Size 9 mm
Flavor TUTTI FRUTTI Imprint Code 187
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69189-5187-11 in 1 DOSE PACK Type 0: Not a Combination Product24/04/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078690 04/24/2015

PRINCIPAL DISPLAY PANEL

Carbidopa/Levodopa 25/100 mg ODT