FDA.reportPublic FDA data

EMEND

Product NDC
0006-0462
11-digit product format
000060462
Labeler code
0006
Product ID
0006-0462_428f7828-6d1c-438b-a17d-b4af0700c740
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aprepitant
Dosage form
CAPSULE
Route
ORAL
Labeler
Merck Sharp & Dohme LLC
Application
NDA021549
Marketing category
NDA
Marketing start
2003-03-26
Substance
APREPITANT
Active strength
125 mg/1
Pharmacologic classes
Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EMEND
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APREPITANT125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1NF15YR6UY
Rxcui403810, 403811, 404465, 404466, 644088, 644278, 754508, 754509, 1729308, 1729311

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2abc3e32-ae1f-4dec-be1c-0c39ac95b38eProduct name720240514
5d352eda-d4de-4572-9a3f-32d6fd204f9aProduct name120230911
3a5d67cc-4a03-45a3-8d74-5aeb67631be4Product name120230831
85fc66a9-58b2-e194-7cdb-89ff44dcf3e6Product name420210518
9f9a82fd-fcee-442f-9233-7f2d2f9f4568Product name120180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-0462-01EMEND6 in 1 BLISTER PACKCAPSULE642
0006-0462-06EMEND1 in 1 CARTONCAPSULE142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0462-01EA - Each0006-04629d4df6e9-f6af-4337-9a21-9541c035157112015-05-05
0006-0462-06EA - Each0006-04623a503cae-e103-4284-af96-a47a8213784012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
aprepitantACTIVE INGREDIENT1NF15YR6UYEMEND (APREPITANT) CAPSULE EMEND (APREPITANT) KIT [MERCK SHARP & DOHME CORP.]24
aprepitantACTIVE MOIETY1NF15YR6UYEMEND (APREPITANT) CAPSULE EMEND (APREPITANT) KIT [MERCK SHARP & DOHME CORP.]24
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UEMEND (APREPITANT) CAPSULE EMEND (APREPITANT) KIT [MERCK SHARP & DOHME CORP.]24
ferric oxide redINACTIVE INGREDIENT1K09F3G675EMEND (APREPITANT) CAPSULE EMEND (APREPITANT) KIT [MERCK SHARP & DOHME CORP.]24
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTEMEND (APREPITANT) CAPSULE EMEND (APREPITANT) KIT [MERCK SHARP & DOHME CORP.]24
gelatinINACTIVE INGREDIENT2G86QN327LEMEND (APREPITANT) CAPSULE EMEND (APREPITANT) KIT [MERCK SHARP & DOHME CORP.]24
hydroxypropyl cellulose (type H)INACTIVE INGREDIENTRFW2ET671PEMEND (APREPITANT) CAPSULE EMEND (APREPITANT) KIT [MERCK SHARP & DOHME CORP.]24
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4EMEND (APREPITANT) CAPSULE EMEND (APREPITANT) KIT [MERCK SHARP & DOHME CORP.]24
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JEMEND (APREPITANT) CAPSULE EMEND (APREPITANT) KIT [MERCK SHARP & DOHME CORP.]24
sucroseINACTIVE INGREDIENTC151H8M554EMEND (APREPITANT) CAPSULE EMEND (APREPITANT) KIT [MERCK SHARP & DOHME CORP.]24
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPEMEND (APREPITANT) CAPSULE EMEND (APREPITANT) KIT [MERCK SHARP & DOHME CORP.]24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-0462EMEND (APREPITANT) CAPSULE EMEND (APREPITANT) KIT EMEND (APREPITANT) POWDER, FOR SUSPENSION [MERCK SHARP & DOHME LLC]41Current NDC, Legacy NDC, 2 package rows20240719_696f9e80-9cae-403b-de9e-078343ce4713.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
754509{1 (aprepitant 125 MG Oral Capsule [Emend]) / 2 (aprepitant 80 MG Oral Capsule [Emend]) } Pack [Emend Tri-Fold Pack]BPCK696f9e80-9cae-403b-de9e-078343ce471342
754508{1 (aprepitant 125 MG Oral Capsule) / 2 (aprepitant 80 MG Oral Capsule) } PackGPCK696f9e80-9cae-403b-de9e-078343ce471342
754508aprepitant 125 MG (1), 80 MG (2) Oral Capsule 3 Count PackPSN696f9e80-9cae-403b-de9e-078343ce471342
403811aprepitant 125 MG Oral CapsulePSN696f9e80-9cae-403b-de9e-078343ce471342
1729308aprepitant 125 MG Powder for Oral SuspensionPSN696f9e80-9cae-403b-de9e-078343ce471342
644088aprepitant 40 MG Oral CapsulePSN696f9e80-9cae-403b-de9e-078343ce471342
403810aprepitant 80 MG Oral CapsulePSN696f9e80-9cae-403b-de9e-078343ce471342
404466Emend 125 MG Oral CapsulePSN696f9e80-9cae-403b-de9e-078343ce471342
1729311Emend 125 MG Powder for Oral SuspensionPSN696f9e80-9cae-403b-de9e-078343ce471342
644278Emend 40 MG Oral CapsulePSN696f9e80-9cae-403b-de9e-078343ce471342
404465Emend 80 MG Oral CapsulePSN696f9e80-9cae-403b-de9e-078343ce471342
754509Emend TriPackPSN696f9e80-9cae-403b-de9e-078343ce471342
404466aprepitant 125 MG Oral Capsule [Emend]SBD696f9e80-9cae-403b-de9e-078343ce471342
1729311aprepitant 125 MG Powder for Oral Suspension [Emend]SBD696f9e80-9cae-403b-de9e-078343ce471342
644278aprepitant 40 MG Oral Capsule [Emend]SBD696f9e80-9cae-403b-de9e-078343ce471342
404465aprepitant 80 MG Oral Capsule [Emend]SBD696f9e80-9cae-403b-de9e-078343ce471342
403811aprepitant 125 MG Oral CapsuleSCD696f9e80-9cae-403b-de9e-078343ce471342
1729308aprepitant 125 MG Powder for Oral SuspensionSCD696f9e80-9cae-403b-de9e-078343ce471342
644088aprepitant 40 MG Oral CapsuleSCD696f9e80-9cae-403b-de9e-078343ce471342
403810aprepitant 80 MG Oral CapsuleSCD696f9e80-9cae-403b-de9e-078343ce471342
404466Emend 125 MG Oral CapsuleSY696f9e80-9cae-403b-de9e-078343ce471342
1729311Emend 125 MG Powder for Oral SuspensionSY696f9e80-9cae-403b-de9e-078343ce471342
644278Emend 40 MG Oral CapsuleSY696f9e80-9cae-403b-de9e-078343ce471342
404465Emend 80 MG Oral CapsuleSY696f9e80-9cae-403b-de9e-078343ce471342
754509Emend Tri-Fold PackSY696f9e80-9cae-403b-de9e-078343ce471342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0006-0462-01000060462016 in 1 BLISTER PACKHistorical
0006-0462-06000060462061 in 1 CARTONHistorical