NDC Code(s) : 43547-435-06
Packager : Solco Healthcare LLC

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:43547-435
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
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSE 2208 (15000 MPA.S)(UNII: Z78RG6M2N2)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-435-0660 in 1 BOTTLE Type 0: Not a Combination Product15/02/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209757 02/15/2018

LABELER - Solco Healthcare LLC(828343017)

PRINCIPAL DISPLAY PANEL

Container Label - 0.1 mg - 60 tablets

NDC 43547-435-06 Rx only
Clonidine Hydrochloride Extended-Release Tablets
0.1 mg per tablet
60 Tablets

Each extended-release tablet contains: 0.1 mg clonidine hydrochloride equivalent to 0.087 mg clonidine.

Usual Dosage: See package insert for full prescribing information.

Clonidine hydrochloride extended-release tablets must be swallowed whole and never crushed, cut or chewed.

Do not substitute clonidine hydrochloride extended-release tablets for other clonidine products.

Keep out of reach of children.

Store at 20° to 25°C(68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Manufactured by:
Xiamen LP Pharmaceutical Co., Ltd.
Xiamen, Fujian 361027, China

Distributed by:
Solco Healthcare US, LLC
Cranbury, NJ 08512, USA

Rev.: 12/2017

PK0029

Clonidine hydrochloride extended-release tablets 0.1 mg - 60 tablets