Aprepitant
These highlights do not include all the information needed to use APREPITANT CAPSULES safely and effectively. See full prescribing information for APREPITANT CAPSULES. APREPITANT capsules, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
d72e0e10-4557-41b0-b65d-d395468cad19
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 28, 2020
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Aprepitant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-112
Application NumberANDA207777
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aprepitant
Product Specifications
Effective DateJanuary 28, 2020
FDA Product Classification
Aprepitant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-584
Application NumberANDA207777
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aprepitant
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 28, 2020
FDA Product Classification
INGREDIENTS (16)
APREPITANTActive
Quantity: 80 mg in 1 1
Code: 1NF15YR6UY
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
VITAMIN E POLYETHYLENE GLYCOL SUCCINATEInactive
Code: O03S90U1F2
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Aprepitant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-583
Application NumberANDA207777
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aprepitant
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 28, 2020
FDA Product Classification
INGREDIENTS (17)
APREPITANTActive
Quantity: 40 mg in 1 1
Code: 1NF15YR6UY
Classification: ACTIB
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
VITAMIN E POLYETHYLENE GLYCOL SUCCINATEInactive
Code: O03S90U1F2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
Aprepitant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-585
Application NumberANDA207777
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aprepitant
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 28, 2020
FDA Product Classification
INGREDIENTS (17)
APREPITANTActive
Quantity: 125 mg in 1 1
Code: 1NF15YR6UY
Classification: ACTIB
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
VITAMIN E POLYETHYLENE GLYCOL SUCCINATEInactive
Code: O03S90U1F2
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT