NDC Code(s) : 52125-179-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Carbidopa and LevodopaCarbidopa and Levodopa TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-179
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
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
FERRIC OXIDE RED(UNII: 1K09F3G675)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
HYPROMELLOSE 2208 (4000 MPA.S)(UNII: 39J80LT57T)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color orange Score no score
Shape OVAL (TABLET, EXTENDED RELEASE) Size 10 mm
Flavor Imprint Code 461
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-179-0230 in 1 BLISTER PACK Type 0: Not a Combination Product10/08/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077828 08/10/2012 01/26/2017

PRINCIPAL DISPLAY PANEL

DRUG: Carbidopa and Levodopa
GENERIC: Carbidopa and Levodopa
DOSAGE: TABLET, EXTENDED RELEASE
ADMINSTRATION: ORAL
NDC: 52125-179-02
STRENGTH:25 mg
COLOR: orange
SHAPE: OVAL
SCORE: No score
SIZE: 10 mm
IMPRINT: 30
QTY: 30

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