NDC Code(s) : 43602-294-07, 43602-294-30, 43602-294-05, 43602-295-07, 43602-295-30, 43602-295-05, 43602-296-07, 43602-296-30, 43602-296-05, 43602-297-07, 43602-297-30, 43602-297-05
Packager : Ascent Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PALIPERIDONEpaliperidone TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-294
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALIPERIDONE(UNII: 838F01T721)
(PALIPERIDONE - UNII:838F01T721) 		PALIPERIDONE1.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE OXIDE 200000(UNII: 11628IH70O)
POLYETHYLENE OXIDE 7000000(UNII: G3MS6M810Y)
STEARIC ACID(UNII: 4ELV7Z65AP)
FD&C RED NO. 40(UNII: WZB9127XOA)
POVIDONE(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
CELLULOSE ACETATE(UNII: 3J2P07GVB6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color yellow Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 15
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-294-077 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
2NDC:43602-294-3030 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
3NDC:43602-294-05500 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216174 08/23/2023
PALIPERIDONEpaliperidone TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-295
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALIPERIDONE(UNII: 838F01T721)
(PALIPERIDONE - UNII:838F01T721) 		PALIPERIDONE3 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE OXIDE 200000(UNII: 11628IH70O)
POLYETHYLENE OXIDE 7000000(UNII: G3MS6M810Y)
STEARIC ACID(UNII: 4ELV7Z65AP)
FD&C RED NO. 40(UNII: WZB9127XOA)
POVIDONE(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
CELLULOSE ACETATE(UNII: 3J2P07GVB6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color pink Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 3
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-295-077 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
2NDC:43602-295-3030 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
3NDC:43602-295-05500 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216174 08/23/2023
PALIPERIDONEpaliperidone TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-296
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALIPERIDONE(UNII: 838F01T721)
(PALIPERIDONE - UNII:838F01T721) 		PALIPERIDONE6 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE OXIDE 200000(UNII: 11628IH70O)
POLYETHYLENE OXIDE 7000000(UNII: G3MS6M810Y)
STEARIC ACID(UNII: 4ELV7Z65AP)
FD&C RED NO. 40(UNII: WZB9127XOA)
POVIDONE(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
CELLULOSE ACETATE(UNII: 3J2P07GVB6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color yellow Score no score
Shape ROUND Size 13 mm
Flavor Imprint Code 6
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-296-077 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
2NDC:43602-296-3030 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
3NDC:43602-296-05500 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216174 08/23/2023
PALIPERIDONEpaliperidone TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-297
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALIPERIDONE(UNII: 838F01T721)
(PALIPERIDONE - UNII:838F01T721) 		PALIPERIDONE9 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE OXIDE 200000(UNII: 11628IH70O)
POLYETHYLENE OXIDE 7000000(UNII: G3MS6M810Y)
STEARIC ACID(UNII: 4ELV7Z65AP)
FD&C RED NO. 40(UNII: WZB9127XOA)
POVIDONE(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
CELLULOSE ACETATE(UNII: 3J2P07GVB6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color yellow Score no score
Shape ROUND Size 13 mm
Flavor Imprint Code 9
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-297-077 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
2NDC:43602-297-3030 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
3NDC:43602-297-05500 in 1 BOTTLE Type 0: Not a Combination Product23/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216174 08/23/2023

LABELER - Ascent Pharmaceuticals, Inc.(080938961)

Establishment
Name Address ID/FEI Business Operations
Ascent Pharmaceuticals, Inc. 080938961 analysis(43602-294, 43602-295, 43602-296, 43602-297), manufacture(43602-294, 43602-295, 43602-296, 43602-297), pack(43602-294, 43602-295, 43602-296, 43602-297)

PRINCIPAL DISPLAY PANEL

1.5 mg 7s

1.5 mg 7s

1.5 mg 7s

1.5 mg 7s

1.5 mg 7s

1.5 mg 7s

1.5 mg 7s

1.5 mg 7s

1.5 mg 7s

1.5 mg 7s

1.5 mg 7s

1.5 mg 7s