FDA.reportPublic FDA data

Fosaprepitant

Product NDC
0591-4385
11-digit product format
005914385
Labeler code
0591
Product ID
0591-4385_89783971-3346-4ff8-ac47-d824a7ddf75d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fosaprepitant
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Actavis Pharma, Inc.
Application
NDA210064
Marketing category
NDA
Marketing start
2019-09-19
Substance
FOSAPREPITANT DIMEGLUMINE
Active strength
150 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
Fosaprepitant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSAPREPITANT DIMEGLUMINE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD35FM8T64X
Rxcui1731077

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
0591-4385-79Fosaprepitant1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-4385-79EA - Each0591-4385bc4f7cf2-9f0d-485f-bf37-4e9bf44107f612019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-4385FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.]12Current NDC, Legacy NDC, 1 package rows20230602_9dbd4c29-d894-4839-9b22-a2f65c8c8ad1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731077fosaprepitant 150 MG InjectionPSN9dbd4c29-d894-4839-9b22-a2f65c8c8ad112
1731077fosaprepitant 150 MG InjectionSCD9dbd4c29-d894-4839-9b22-a2f65c8c8ad112
1731077fosaprepitant 150 MG (as fosaprepitant dimeglumine 245.3 MG) InjectionSY9dbd4c29-d894-4839-9b22-a2f65c8c8ad112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-4385-79005914385791 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0591-4385-79) 2019-09-190000-00-00NoNoCurrent