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EMEND

These highlights do not include all the information needed to use EMEND CAPSULES and EMEND FOR ORAL SUSPENSION safely and effectively. See full prescribing information for EMEND CAPSULES and EMEND FOR ORAL SUSPENSION. EMEND (aprepitant) capsules, for oral use EMEND (aprepitant) for oral suspension Initial U.S. Approval: 2003

Approved
Approval ID

696f9e80-9cae-403b-de9e-078343ce4713

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 1, 2023

Manufacturers
FDA

Merck Sharp & Dohme LLC

DUNS: 118446553

Products 5

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 Code0006-0464
Application NumberNDA021549
Product Classification
M
Marketing Category
C73594
G
Generic Name
aprepitant
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2022
FDA Product Classification

INGREDIENTS (9)

aprepitantActive
Quantity: 40 mg in 1 1
Code: 1NF15YR6UY
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT

aprepitant

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0006-3066
Application NumberNDA207865
Product Classification
M
Marketing Category
C73594
G
Generic Name
aprepitant
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2022
FDA Product Classification

INGREDIENTS (7)

sucroseInactive
Code: C151H8M554
Classification: IACT
aprepitantActive
Quantity: 125 mg in 1 1
Code: 1NF15YR6UY
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
sodium stearyl fumarateInactive
Code: 7CV7WJK4UI
Classification: IACT

aprepitant

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0006-3862
Application NumberNDA021549
Product Classification
M
Marketing Category
C73594
G
Generic Name
aprepitant
Product Specifications
Effective DateMay 6, 2022
FDA Product Classification

aprepitant

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0006-0461
Application NumberNDA021549
Product Classification
M
Marketing Category
C73594
G
Generic Name
aprepitant
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2022
FDA Product Classification

INGREDIENTS (8)

aprepitantActive
Quantity: 80 mg in 1 1
Code: 1NF15YR6UY
Classification: ACTIB
sucroseInactive
Code: C151H8M554
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT

aprepitant

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0006-0462
Application NumberNDA021549
Product Classification
M
Marketing Category
C73594
G
Generic Name
aprepitant
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2022
FDA Product Classification

INGREDIENTS (10)

aprepitantActive
Quantity: 125 mg in 1 1
Code: 1NF15YR6UY
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

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