FDA.reportPublic FDA data

Fosaprepitant

Product NDC
43598-859
11-digit product format
435980859
Labeler code
43598
Product ID
43598-859_72a1e18f-9377-5bc3-4638-32d7212872b6
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
2019-09-06
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
43598-859-11Fosaprepitant1 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,13
43598-859-11Fosaprepitant1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-859-11EA - Each43598-85916e8318e-d878-4f12-a813-4e7b61334b7312019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-859FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES INC.,]3Current NDC, Legacy NDC, 2 package rows20241222_f34c931c-78b9-90c1-3fa5-bb34a227f2ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731077fosaprepitant 150 MG InjectionPSNf34c931c-78b9-90c1-3fa5-bb34a227f2ad3
1731077fosaprepitant 150 MG InjectionSCDf34c931c-78b9-90c1-3fa5-bb34a227f2ad3
1731077fosaprepitant 150 MG (as fosaprepitant dimeglumine 245.3 MG) InjectionSYf34c931c-78b9-90c1-3fa5-bb34a227f2ad3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-859-11435980859111 VIAL in 1 CARTON (43598-859-11) / 1 mL in 1 VIAL1 vial2019-09-060000-00-00NoNoCurrent