NDC Code(s) : 52125-990-02
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:52125-990(NDC:0603-2959)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE(UNII: W76I6XXF06)
(CLONIDINE - UNII:MN3L5RMN02) 		CLONIDINE HYDROCHLORIDE0.3 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: L11K75P92J)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color pink (peach) Score 2 pieces
Shape OVAL Size 8 mm
Flavor Imprint Code 25;43;V
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-990-0230 in 1 BLISTER PACK Type 0: Not a Combination Product21/07/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077901 07/21/2014 06/29/2017

PRINCIPAL DISPLAY PANEL

DRUG: Clonidine Hydrochloride

GENERIC: clonidine hydrochloride

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-990-02

COLOR: pink

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 8 mm

IMPRINT: 25;43;V

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • CLONIDINE HYDROCHLORIDE 0.300mg in 1

INACTIVE INGREDIENT(S):

  • CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
  • CELLULOSE, MICROCRYSTALLINE
  • SODIUM LAURYL SULFATE
  • MAGNESIUM STEARATE
  • FD&C YELLOW NO. 6
  • LACTOSE MONOHYDRATE
  • SODIUM STARCH GLYCOLATE TYPE A POTATO

/xml/0071a67f-be68-4910-a003-5de154cb3c24/Remedy_Label.jpg