NDC Code(s) : 68462-583-11, 68462-583-85, 68462-583-40, 68462-584-58, 68462-584-76, 68462-585-76, 68462-112-33
Packager : Glenmark Pharmaceuticals Inc., USA

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AprepitantAprepitant CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-583
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
APREPITANT(UNII: 1NF15YR6UY)
(APREPITANT - UNII:1NF15YR6UY) 		APREPITANT40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)(UNII: 8136Y38GY5)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
MANNITOL(UNII: 3OWL53L36A)
POLOXAMER 407(UNII: TUF2IVW3M2)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE(UNII: O03S90U1F2)
WATER(UNII: 059QF0KO0R)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Product Characteristics
Color YELLOW (mustard [cap]), WHITE (opaque [body]) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code G;583
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-583-111 in 1 CARTON 10/12/2017
110 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:68462-583-855 in 1 CARTON 10/12/2017
21 in 1 BLISTER PACK Type 0: Not a Combination Product
3NDC:68462-583-401 in 1 CARTON 10/12/2017
31 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207777 10/12/2017
AprepitantAprepitant CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-584
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
APREPITANT(UNII: 1NF15YR6UY)
(APREPITANT - UNII:1NF15YR6UY) 		APREPITANT80 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)(UNII: 8136Y38GY5)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
MANNITOL(UNII: 3OWL53L36A)
POLOXAMER 407(UNII: TUF2IVW3M2)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE(UNII: O03S90U1F2)
WATER(UNII: 059QF0KO0R)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Product Characteristics
Color WHITE (opaque [cap]), WHITE (opaque [body]) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code G;584
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-584-582 in 1 DOSE PACK Type 0: Not a Combination Product10/12/2017
2NDC:68462-584-761 in 1 CARTON 10/12/2017
26 in 1 BLISTER PACK Type 0: Not a Combination Product10/12/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207777 10/12/2017
AprepitantAprepitant CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-585
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
APREPITANT(UNII: 1NF15YR6UY)
(APREPITANT - UNII:1NF15YR6UY) 		APREPITANT125 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)(UNII: 8136Y38GY5)
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE(UNII: O03S90U1F2)
POLOXAMER 407(UNII: TUF2IVW3M2)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
MANNITOL(UNII: 3OWL53L36A)
WATER(UNII: 059QF0KO0R)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Product Characteristics
Color PINK (opaque [cap]), WHITE (opaque [body]) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code G;585
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-585-761 in 1 CARTON 10/12/2017
16 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207777 10/12/2017
AprepitantAprepitant KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-112
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)(UNII: 8136Y38GY5)
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE(UNII: O03S90U1F2)
POLOXAMER 407(UNII: TUF2IVW3M2)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
MANNITOL(UNII: 3OWL53L36A)
WATER(UNII: 059QF0KO0R)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)(UNII: 8136Y38GY5)
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE(UNII: O03S90U1F2)
POLOXAMER 407(UNII: TUF2IVW3M2)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
MANNITOL(UNII: 3OWL53L36A)
WATER(UNII: 059QF0KO0R)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-112-331 in 1 DOSE PACK Type 0: Not a Combination Product10/12/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207777 10/12/2017

LABELER - Glenmark Pharmaceuticals Inc., USA(130597813)

Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Limited 862603186 MANUFACTURE(68462-583, 68462-584, 68462-585, 68462-112), ANALYSIS(68462-583, 68462-584, 68462-585, 68462-112)

PRINCIPAL DISPLAY PANEL

40mg-1caps

PRINCIPAL DISPLAY PANEL

80mg-6cap

PRINCIPAL DISPLAY PANEL

125mg-6caps

PRINCIPAL DISPLAY PANEL

125mg-80mg-3cap