NDC Code 43602-296-30 - Paliperidone

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PALIPERIDONE(UNII: 838F01T721) (PALIPERIDONE - UNII:838F01T721)	PALIPERIDONE	1.5 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-294-07	7 in 1 BOTTLE Type 0: Not a Combination Product	23/08/2023
2	NDC:43602-294-30	30 in 1 BOTTLE Type 0: Not a Combination Product	23/08/2023
3	NDC:43602-294-05	500 in 1 BOTTLE Type 0: Not a Combination Product	23/08/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PALIPERIDONE(UNII: 838F01T721) (PALIPERIDONE - UNII:838F01T721)	PALIPERIDONE	3 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-295-07	7 in 1 BOTTLE Type 0: Not a Combination Product	23/08/2023
2	NDC:43602-295-30	30 in 1 BOTTLE Type 0: Not a Combination Product	23/08/2023
3	NDC:43602-295-05	500 in 1 BOTTLE Type 0: Not a Combination Product	23/08/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PALIPERIDONE(UNII: 838F01T721) (PALIPERIDONE - UNII:838F01T721)	PALIPERIDONE	6 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-296-07	7 in 1 BOTTLE Type 0: Not a Combination Product	23/08/2023
2	NDC:43602-296-30	30 in 1 BOTTLE Type 0: Not a Combination Product	23/08/2023
3	NDC:43602-296-05	500 in 1 BOTTLE Type 0: Not a Combination Product	23/08/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PALIPERIDONE(UNII: 838F01T721) (PALIPERIDONE - UNII:838F01T721)	PALIPERIDONE	9 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-297-07	7 in 1 BOTTLE Type 0: Not a Combination Product	23/08/2023
2	NDC:43602-297-30	30 in 1 BOTTLE Type 0: Not a Combination Product	23/08/2023
3	NDC:43602-297-05	500 in 1 BOTTLE Type 0: Not a Combination Product	23/08/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

NDC 43602-296-30
API & Excipient Details

Paliperidone marketed by Ascent Pharmaceuticals, Inc. under NDC Code 43602-296-30

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.

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 43602-296-30 API & Excipient Details

Paliperidone marketed by Ascent Pharmaceuticals, Inc. under NDC Code 43602-296-30

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, 43602-297-05Packager : Ascent Pharmaceuticals, Inc.

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 43602-296-30
API & Excipient Details

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.