Fosaprepitant

Product NDC
43598-948
11-digit product format
435980948
Labeler code
43598
Product ID
43598-948_947d6239-8b25-5225-b257-71e8a98b5aae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosaprepitant
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Dr. Reddy's Laboratories Inc.,
Application
ANDA209965
Marketing category
ANDA
Marketing start
2020-07-01
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
43598-948-11Fosaprepitant1 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,11
43598-948-11Fosaprepitant1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-948FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES INC.,]1Current NDC, Legacy NDC, 2 package rows20200702_d624667d-ee3b-3501-53fe-da453352042d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731077fosaprepitant 150 MG InjectionPSNd624667d-ee3b-3501-53fe-da453352042d1
1731077fosaprepitant 150 MG InjectionSCDd624667d-ee3b-3501-53fe-da453352042d1
1731077fosaprepitant 150 MG (as fosaprepitant dimeglumine 245.3 MG) InjectionSYd624667d-ee3b-3501-53fe-da453352042d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-948-11435980948111 VIAL in 1 CARTON (43598-948-11) / 1 mL in 1 VIAL1 vial2020-07-010000-00-00NoNoCurrent