NDC Code(s) : 0228-4241-06
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clonidine HydrochlorideClonidine Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-4241
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(UNII: R33S7TK2EP)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color pink Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 241
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-4241-0660 in 1 BOTTLE Type 0: Not a Combination Product17/06/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203320 06/17/2015

LABELER - Actavis Pharma, Inc.(119723554)

PRINCIPAL DISPLAY PANEL

NDC 0228-4241-06

Clonidine Hydrochloride Extended-Release Tablets, USP

0.1 mg

Rx only

60 Tablets

Container 0.1 mg, 60 Tablets