FDA.reportPublic FDA data

fosaprepitant

Product NDC
71839-104
11-digit product format
718390104
Labeler code
71839
Product ID
71839-104_1b1fe4ce-02d6-4ca1-8168-37b099caa434
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fosaprepitant
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
BE Pharmaceuticals Inc.
Application
ANDA212309
Marketing category
ANDA
Marketing start
2019-10-15
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
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/5mL

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
71839-104-01fosaprepitant5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,59
71839-104-01fosaprepitant1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71839-104-01EA - Each71839-104493682f6-a576-4421-a2f7-49a1a9e2cf3812019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71839-104FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BE PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 2 package rows20240926_21b08b87-70e3-4233-9531-dd6d84eab5d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731077fosaprepitant 150 MG InjectionPSN21b08b87-70e3-4233-9531-dd6d84eab5d09
1731077fosaprepitant 150 MG InjectionSCD21b08b87-70e3-4233-9531-dd6d84eab5d09
1731077fosaprepitant 150 MG (as fosaprepitant dimeglumine 245.3 MG) InjectionSY21b08b87-70e3-4233-9531-dd6d84eab5d09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71839-104-01718390104011 VIAL, SINGLE-DOSE in 1 CARTON (71839-104-01) / 5 mL in 1 VIAL, SINGLE-DOSE2019-10-150000-00-00NoNoCurrent