NDC Code(s) : 52125-171-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clonidine Hydrochlorideclonidine hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-171(NDC:0378-0152)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE(UNII: W76I6XXF06)
(CLONIDINE - UNII:MN3L5RMN02) 		CLONIDINE HYDROCHLORIDE0.1 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIUM CHLORIDE(UNII: 01Q9PC255D)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color white Score 2 pieces
Shape ROUND (TABLET) Size 6 mm
Flavor Imprint Code MYLAN;152
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-171-0230 in 1 BLISTER PACK Type 0: Not a Combination Product16/08/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070317 08/16/2012 06/15/2017

PRINCIPAL DISPLAY PANEL

DRUG: Clonidine Hydrochloride

GENERIC: clonidine hydrochloride

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-171-02

STRENGTH:0.1 mg

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 6 mm

IMPRINT: 30

QTY: 30

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