NDC Code(s) : 0228-2127-10, 0228-2127-50, 0228-2128-10, 0228-2128-50, 0228-2129-10
Packager : Actavis Pharma, 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:0228-2127
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
STARCH, CORN(UNII: O8232NY3SJ)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color orange Score 2 pieces
Shape ROUND Size 6 mm
Flavor Imprint Code R127
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-2127-10100 in 1 BOTTLE Type 0: Not a Combination Product01/03/1995
2NDC:0228-2127-50500 in 1 BOTTLE Type 0: Not a Combination Product01/03/1995
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070974 01/03/1995
Clonidine HydrochlorideClonidine Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-2128
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE(UNII: W76I6XXF06)
(CLONIDINE - UNII:MN3L5RMN02) 		CLONIDINE HYDROCHLORIDE0.2 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color orange Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code R128
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-2128-10100 in 1 BOTTLE Type 0: Not a Combination Product01/03/1995
2NDC:0228-2128-50500 in 1 BOTTLE Type 0: Not a Combination Product01/03/1995
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070975 01/03/1995
Clonidine HydrochlorideClonidine Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-2129
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
STARCH, CORN(UNII: O8232NY3SJ)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color orange Score 2 pieces
Shape ROUND Size 9 mm
Flavor Imprint Code R129
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-2129-10100 in 1 BOTTLE Type 0: Not a Combination Product01/03/1995
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070976 01/03/1995

LABELER - Actavis Pharma, Inc.(119723554)

PRINCIPAL DISPLAY PANEL

NDC 0228-2127-10

Clonidine Hydrochloride Tablets, USP

0.1 mg

Rx only

100 Tablets

1

PRINCIPAL DISPLAY PANEL

NDC 0228-2128-10

Clonidine Hydrochloride Tablets, USP

0.2 mg

Rx only

100 Tablets

1

PRINCIPAL DISPLAY PANEL

NDC 0228-2129-10

Clonidine Hydrochloride Tablets, USP

0.3 mg

Rx only

100 Tablets

1