FDA.reportPublic FDA data

Fosaprepitant

Product NDC
63323-972
11-digit product format
633230972
Labeler code
63323
Product ID
63323-972_864bb02f-d50d-4ae2-ad9c-82bb1e9aed2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FOSAPREPITANT
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA206197
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
63323-972-10Fosaprepitant1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,17
63323-972-10Fosaprepitant10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-972-10EA - Each63323-972deb3f940-2fc7-414d-92bc-6150aed70b9412019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-972FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 2 package rows20240712_ffee61d1-c1c6-4224-871c-ab7ff6cd01e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731077fosaprepitant 150 MG InjectionPSNffee61d1-c1c6-4224-871c-ab7ff6cd01e57
1731077fosaprepitant 150 MG InjectionSCDffee61d1-c1c6-4224-871c-ab7ff6cd01e57
1731077fosaprepitant 150 MG (as fosaprepitant dimeglumine 245.3 MG) InjectionSYffee61d1-c1c6-4224-871c-ab7ff6cd01e57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63323-972-10633230972101 VIAL, SINGLE-DOSE in 1 CARTON (63323-972-10) / 10 mL in 1 VIAL, SINGLE-DOSE2019-09-050000-00-00NoNoCurrent