NDC Code(s) : 64720-228-10, 64720-229-10, 64720-230-10
Packager : CorePharma, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Molindone HydrochlorideMolindone Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64720-228
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOLINDONE HYDROCHLORIDE(UNII: 1DWS68PNE6)
(MOLINDONE - UNII:RT3Y3QMF8N) 		MOLINDONE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient Name Strength
ALGINIC ACID(UNII: 8C3Z4148WZ)
CALCIUM SULFATE(UNII: WAT0DDB505)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 8 mm
Flavor Imprint Code cor;228
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64720-228-10100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/09/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090453 09/15/2015 07/31/2017
Molindone HydrochlorideMolindone Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64720-229
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOLINDONE HYDROCHLORIDE(UNII: 1DWS68PNE6)
(MOLINDONE - UNII:RT3Y3QMF8N) 		MOLINDONE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
ALGINIC ACID(UNII: 8C3Z4148WZ)
CALCIUM SULFATE(UNII: WAT0DDB505)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 8 mm
Flavor Imprint Code cor;229
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64720-229-10100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/09/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090453 09/15/2015 02/28/2018
Molindone HydrochlorideMolindone Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64720-230
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOLINDONE HYDROCHLORIDE(UNII: 1DWS68PNE6)
(MOLINDONE - UNII:RT3Y3QMF8N) 		MOLINDONE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient Name Strength
ALGINIC ACID(UNII: 8C3Z4148WZ)
CALCIUM SULFATE(UNII: WAT0DDB505)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color GREEN Score 2 pieces
Shape OVAL Size 11 mm
Flavor Imprint Code cor;230
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64720-230-10100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/09/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090453 09/15/2015 03/31/2018

PRINCIPAL DISPLAY PANEL

Molindone Hydrochloride Tablets, USP
5 mg - 100 Tablets
NDC 64720-228-10

Molindone Hydrochloride Tablets, USP - 5 mg, 100 Tablets

PRINCIPAL DISPLAY PANEL

Molindone Hydrochloride Tablets, USP
10 mg - 100 Tablets
NDC 64720-229-10 

Molindone Hydrochloride Tablets, USP - 10 mg, 100 Tablets

PRINCIPAL DISPLAY PANEL

Molindone Hydrochloride Tablets, USP
25 mg - 100 Tablets
NDC 64720-230-10

Molindone Hydrochloride Tablets, USP - 25 mg, 100 Tablets