FDA.reportPublic FDA data

EMEND

Product NDC
0006-3061
11-digit product format
000063061
Labeler code
0006
Product ID
0006-3061_20906e8e-8a3e-4c45-a657-6d4c1945af09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FOSAPREPITANT DIMEGLUMINE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Merck Sharp & Dohme LLC
Application
NDA022023
Marketing category
NDA
Marketing start
2017-02-03
Substance
FOSAPREPITANT DIMEGLUMINE
Active strength
150 mg/5mL
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EMEND
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSAPREPITANT DIMEGLUMINE150 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD35FM8T64X
Rxcui1731077, 1731082

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
0006-3061-00EMEND1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,120
0006-3061-01EMEND5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,520

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-3061-00EA - Each0006-3061136fbe9b-7f31-4ce1-acb2-16d66d0c0bc712017-07-07
0006-3061-01EA - Each0006-3061bc8e7553-f2ce-4c6e-ab40-829bbeb9fddd12018-03-08
0006-3061-02EA - Each0006-30616734df7f-a0c7-4344-9a9a-887329f5586d12019-08-06
0006-3061-03EA - Each0006-3061c4d6bb40-a295-48c8-bba4-3889616b3aff12020-07-13
0006-3061-04EA - Each0006-3061585908e3-6134-4f36-84c6-2d2e17be473012019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-3061EMEND (FOSAPREPITANT DIMEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC]18Current NDC, Legacy NDC, 2 package rows20240111_8d66803a-6811-4c29-9c57-e16acfa87f21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731082Emend 150 MG InjectionPSN8d66803a-6811-4c29-9c57-e16acfa87f2120
1731077fosaprepitant 150 MG InjectionPSN8d66803a-6811-4c29-9c57-e16acfa87f2120
1731082fosaprepitant 150 MG Injection [Emend Injection]SBD8d66803a-6811-4c29-9c57-e16acfa87f2120
1731077fosaprepitant 150 MG InjectionSCD8d66803a-6811-4c29-9c57-e16acfa87f2120
1731082Emend 150 MG (as fosaprepitant dimeglumine 245.3 MG) InjectionSY8d66803a-6811-4c29-9c57-e16acfa87f2120
1731077fosaprepitant 150 MG (as fosaprepitant dimeglumine 245.3 MG) InjectionSY8d66803a-6811-4c29-9c57-e16acfa87f2120

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-3061-00000063061001 VIAL, SINGLE-DOSE in 1 CARTON (0006-3061-00) / 5 mL in 1 VIAL, SINGLE-DOSE (0006-3061-01) 2017-02-030000-00-00NoNoCurrent
0006-3061-01000063061015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
0006-3061-02000063061021 VIAL, SINGLE-DOSE in 1 CARTON (0006-3061-02) > 5 mL in 1 VIAL, SINGLE-DOSE (0006-3061-03) 2017-02-030000-00-00NoNoCurrent
0006-3061-04000063061041 VIAL, SINGLE-DOSE in 1 CARTON (0006-3061-04) > 5 mL in 1 VIAL, SINGLE-DOSE (0006-3061-01) 2017-02-030000-00-00NoNoCurrent