FDA.reportPublic FDA data

Fosaprepitant

Product NDC
72603-450
11-digit product format
726030450
Labeler code
72603
Product ID
72603-450_bf207918-100d-4917-88b0-3433c0e72249
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosaprepitant
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Northstar Rx LLC
Application
ANDA209965
Marketing category
ANDA
Marketing start
2019-09-05
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
72603-450-01Fosaprepitant1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
72603-450-01Fosaprepitant5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-450-01EA - Each72603-45073ee7e04-59ba-4fbf-ab8e-ff9553a30fd412025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-450FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NORTHSTAR RX LLC]1Current NDC, 2 package rows20250122_bf207918-100d-4917-88b0-3433c0e72249.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731077fosaprepitant 150 MG InjectionPSNbf207918-100d-4917-88b0-3433c0e722491
1731077fosaprepitant 150 MG InjectionSCDbf207918-100d-4917-88b0-3433c0e722491
1731077fosaprepitant 150 MG (as fosaprepitant dimeglumine 245.3 MG) InjectionSYbf207918-100d-4917-88b0-3433c0e722491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-450-01726030450011 VIAL, SINGLE-DOSE in 1 CARTON (72603-450-01) / 5 mL in 1 VIAL, SINGLE-DOSE2025-04-01NoNoCurrent