FDA.reportPublic FDA data

FOCINVEZ

Product NDC
70121-2631
11-digit product format
701212631
Labeler code
70121
Product ID
70121-2631_0ef109ec-d2f8-4c22-b20d-65db7f9c85a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FOSAPREPITANT DIMEGLUMINE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
NDA216686
Marketing category
NDA
Marketing start
2024-06-01
Substance
FOSAPREPITANT DIMEGLUMINE
Active strength
150 mg/50mL
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
FOCINVEZ
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSAPREPITANT DIMEGLUMINE150 mg/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD35FM8T64X
Rxcui2664065, 2664071

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
70121-2631-1FOCINVEZ50 mL in 1 VIAL, SINGLE-DOSEINJECTION507
70121-2631-1FOCINVEZ1 in 1 CARTONINJECTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-2631-1ML - Milliliter70121-263151b88ecb-8b73-4d82-9785-9c8a4a31caea12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-2631FOCINVEZ (FOSAPREPITANT DIMEGLUMINE) INJECTION [AMNEAL PHARMACEUTICALS LLC]5Current NDC, 2 package rows20240606_7afe33d8-5416-465a-b98b-f4eedc327a94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2664071FOCINVEZ 150 MG in 50 ML InjectionPSN7afe33d8-5416-465a-b98b-f4eedc327a947
2664065fosaprepitant 150 MG in 50 ML InjectionPSN7afe33d8-5416-465a-b98b-f4eedc327a947
266407150 ML fosaprepitant 3 MG/ML Injection [Focinvez]SBD7afe33d8-5416-465a-b98b-f4eedc327a947
266406550 ML fosaprepitant 3 MG/ML InjectionSCD7afe33d8-5416-465a-b98b-f4eedc327a947
266407150 ML Focinvez 3 MG/ML InjectionSY7afe33d8-5416-465a-b98b-f4eedc327a947
2664071Focinvez 150 MG per 50 ML InjectionSY7afe33d8-5416-465a-b98b-f4eedc327a947
2664065fosaprepitant 150 MG per 50 ML InjectionSY7afe33d8-5416-465a-b98b-f4eedc327a947

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70121-2631-1701212631011 VIAL, SINGLE-DOSE in 1 CARTON (70121-2631-1) / 50 mL in 1 VIAL, SINGLE-DOSE2024-06-15NoNoCurrent