FDA.reportPublic FDA data

Fosaprepitant

Product NDC
43598-671
11-digit product format
435980671
Labeler code
43598
Product ID
43598-671_aaffcc4e-88e7-4544-bedb-b508fddebd24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosaprepitant
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Dr. Reddy's Laboratories Inc.,
Application
ANDA211160
Marketing category
ANDA
Marketing start
2026-02-12
Substance
FOSAPREPITANT DIMEGLUMINE
Active strength
150 mg/1
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fosaprepitant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSAPREPITANT DIMEGLUMINE150 mg/1

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
43598-671-11Fosaprepitant1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,19
43598-671-11Fosaprepitant1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-671FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES INC.,]8Current NDC, 2 package rows20241211_557a48d5-0e1f-f3d5-d3bc-db422d19c399.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731077fosaprepitant 150 MG InjectionPSN557a48d5-0e1f-f3d5-d3bc-db422d19c3999
1731077fosaprepitant 150 MG InjectionSCD557a48d5-0e1f-f3d5-d3bc-db422d19c3999
1731077fosaprepitant 150 MG (as fosaprepitant dimeglumine 245.3 MG) InjectionSY557a48d5-0e1f-f3d5-d3bc-db422d19c3999

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43598-671-11435980671111 VIAL, SINGLE-DOSE in 1 CARTON (43598-671-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2026-02-12NoNoCurrent