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 useInitial U.S. Approval: 2003
Approved
Approval ID
f58b8944-93ee-4be1-a238-cc0061ddd93a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 24, 2020
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
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 Code0781-2323
Application NumberANDA090999
Product Classification
M
Marketing Category
C73584
G
Generic Name
aprepitant
Product Specifications
Route of AdministrationORAL
Effective DateDecember 24, 2020
FDA Product Classification
INGREDIENTS (11)
APREPITANTActive
Quantity: 125 mg in 1 1
Code: 1NF15YR6UY
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
aprepitant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-2321
Application NumberANDA090999
Product Classification
M
Marketing Category
C73584
G
Generic Name
aprepitant
Product Specifications
Route of AdministrationORAL
Effective DateDecember 24, 2020
FDA Product Classification
INGREDIENTS (10)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
APREPITANTActive
Quantity: 40 mg in 1 1
Code: 1NF15YR6UY
Classification: ACTIB
SHELLACInactive
Code: 46N107B71O
Classification: IACT
aprepitant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-4063
Application NumberANDA090999
Product Classification
M
Marketing Category
C73584
G
Generic Name
aprepitant
Product Specifications
Effective DateDecember 24, 2020
FDA Product Classification
aprepitant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-2322
Application NumberANDA090999
Product Classification
M
Marketing Category
C73584
G
Generic Name
aprepitant
Product Specifications
Route of AdministrationORAL
Effective DateDecember 24, 2020
FDA Product Classification
INGREDIENTS (10)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
APREPITANTActive
Quantity: 80 mg in 1 1
Code: 1NF15YR6UY
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT