FDA.reportPublic FDA data

EMEND

Product NDC
0006-0464
11-digit product format
000060464
Labeler code
0006
Product ID
0006-0464_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
40 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0006-04640006-0464-05DDiscontinued by firm2026-07-31
excluded packagepackage0006-04640006-0464-10DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021549-001EMENDAPREPITANT80MGCAPSULE / ORALABRLD2003-03-26
N021549-002EMENDAPREPITANT125MGCAPSULE / ORALABRLD, RS2003-03-26
N021549-003EMENDAPREPITANT40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2006-06-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021549-001AB
N021549-002AB

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021549-00182581322027-09-26U-1743Drug product2012-09-27
N021549-00182581322027-09-26U-901Drug product2012-09-27
N021549-00282581322027-09-26U-1743Drug product
N021549-00282581322027-09-26U-901Drug product
N021549-00382581322027-09-26U-1743Drug product
N021549-00382581322027-09-26U-901Drug product

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021549-001EMEND80MGCAPSULE / ORALABRLD2003-03-26a50c72e98297…
2026-08-01 22:54:322026-06N021549-002EMEND125MGCAPSULE / ORALABRLD, RS2003-03-26a50c72e98297…
2026-08-01 22:54:322026-06N021549-003EMEND40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2006-06-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021549-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N021549-002AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N021549-00182581322027-09-26U-1743Drug product2012-09-27a50c72e98297…
2026-08-01 22:54:322026-06N021549-00182581322027-09-26U-901Drug product2012-09-27a50c72e98297…
2026-08-01 22:54:322026-06N021549-00282581322027-09-26U-901Drug producta50c72e98297…
2026-08-01 22:54:322026-06N021549-00282581322027-09-26U-1743Drug producta50c72e98297…
2026-08-01 22:54:322026-06N021549-00382581322027-09-26U-901Drug producta50c72e98297…
2026-08-01 22:54:322026-06N021549-00382581322027-09-26U-1743Drug producta50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EMENDAPREPITANTMerck Sharp & Dohme LLC696f9e80-9cae-403b-de9e-078343ce47132024-07-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 021549
application number: NDA021549
ndc (product): 0006-0464

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APREPITANT40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1NF15YR6UYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
403810Internal RxNorm lookup
403811Internal RxNorm lookup
404465Internal RxNorm lookup
404466Internal RxNorm lookup
644088Internal RxNorm lookup
644278Internal RxNorm lookup
754508Internal RxNorm lookup
754509Internal RxNorm lookup
1729308Internal RxNorm lookup
1729311Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
696f9e80-9cae-403b-de9e-078343ce4713Available on FDA.report

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
0006-0464-01EMEND1 in 1 BLISTER PACKCAPSULE142
0006-0464-05EMEND5 in 1 CARTONCAPSULE542
0006-0464-10EMEND1 in 1 CARTONCAPSULE142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0464-01EA - Each0006-0464aa59b87f-95cf-434e-bbba-071bd01914c812015-05-05
0006-0464-05EA - Each0006-04646950bb7f-2ffe-4212-a961-2b5728546d6712012-07-24
0006-0464-10EA - Each0006-0464dcff8790-2ab6-464f-9e8b-5eca5e15ca1412012-07-24

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
aprepitantACTIVE INGREDIENT1NF15YR6UYEMEND (APREPITANT) CAPSULE [REBEL DISTRIBUTORS CORP]1
aprepitantACTIVE MOIETY1NF15YR6UYEMEND (APREPITANT) CAPSULE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEMEND (APREPITANT) CAPSULE [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEMEND (APREPITANT) CAPSULE [REBEL DISTRIBUTORS CORP]1
gelatinINACTIVE INGREDIENT2G86QN327LEMEND (APREPITANT) CAPSULE [REBEL DISTRIBUTORS CORP]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PEMEND (APREPITANT) CAPSULE [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4EMEND (APREPITANT) CAPSULE [REBEL DISTRIBUTORS CORP]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JEMEND (APREPITANT) CAPSULE [REBEL DISTRIBUTORS CORP]1
sucroseINACTIVE INGREDIENTC151H8M554EMEND (APREPITANT) CAPSULE [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPEMEND (APREPITANT) CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-0464EMEND (APREPITANT) CAPSULE EMEND (APREPITANT) KIT EMEND (APREPITANT) POWDER, FOR SUSPENSION [MERCK SHARP & DOHME LLC]41Current NDC, Legacy NDC, 3 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
644088aprepitant 40 MG Oral CapsulePSNec44482e-6194-4829-a3f7-ebe8d48a41a51
644278Emend 40 MG Oral CapsulePSNec44482e-6194-4829-a3f7-ebe8d48a41a51
644278aprepitant 40 MG Oral Capsule [Emend]SBDec44482e-6194-4829-a3f7-ebe8d48a41a51
644088aprepitant 40 MG Oral CapsuleSCDec44482e-6194-4829-a3f7-ebe8d48a41a51
644278Emend 40 MG Oral CapsuleSYec44482e-6194-4829-a3f7-ebe8d48a41a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0006-0464-01000060464011 in 1 BLISTER PACKHistorical
0006-0464-05000060464055 in 1 CARTONHistorical
0006-0464-10000060464101 in 1 CARTONHistorical