FDA.reportPublic FDA data

FOSAPREPITANT DIMEGLUMINE

Product NDC
55150-299
11-digit product format
551500299
Labeler code
55150
Product ID
55150-299_cfb1b23b-6aa1-404b-a652-8347d5c36d7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FOSAPREPITANT DIMEGLUMINE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA210625
Marketing category
ANDA
Marketing start
2021-01-12
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
55150-299-01FOSAPREPITANT DIMEGLUMINE5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,57
55150-299-01FOSAPREPITANT DIMEGLUMINE1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-299-01EA - Each55150-2993b63c36d-f67c-4801-b523-eff9f397f1ba12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-299FOSAPREPITANT DIMEGLUMINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC]6Current NDC, Legacy NDC, 2 package rows20240222_19919480-960b-4741-9611-c133d68512f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731077fosaprepitant 150 MG InjectionPSN19919480-960b-4741-9611-c133d68512f57
1731077fosaprepitant 150 MG InjectionSCD19919480-960b-4741-9611-c133d68512f57
1731077fosaprepitant 150 MG (as fosaprepitant dimeglumine 245.3 MG) InjectionSY19919480-960b-4741-9611-c133d68512f57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-299-01551500299011 VIAL, SINGLE-DOSE in 1 CARTON (55150-299-01) / 5 mL in 1 VIAL, SINGLE-DOSE2021-01-120000-00-00NoNoCurrent