FDA.reportPublic FDA data

Fosaprepitant

Product NDC
72205-054
11-digit product format
722050054
Labeler code
72205
Product ID
72205-054_604e47a7-2f8f-40f8-9595-00b09be51e40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosaprepitant
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA209965
Marketing category
ANDA
Marketing start
2020-05-12
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
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
72205-054-01Fosaprepitant1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12
72205-054-01Fosaprepitant5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-054-01EA - Each72205-054bce494e7-0ae9-469b-a208-07d7ee63c8d312020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-054FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, Legacy NDC, 2 package rows20200513_1e6b36b2-3c8b-4ac4-827e-d6f00d999032.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731077fosaprepitant 150 MG InjectionPSN679c195a-cf59-4ca5-aa05-fa35d08ddb5c100
1731077fosaprepitant 150 MG InjectionSCD679c195a-cf59-4ca5-aa05-fa35d08ddb5c100
1731077fosaprepitant 150 MG (as fosaprepitant dimeglumine 245.3 MG) InjectionSY679c195a-cf59-4ca5-aa05-fa35d08ddb5c100
1731077fosaprepitant 150 MG InjectionPSN1e6b36b2-3c8b-4ac4-827e-d6f00d9990322
1731077fosaprepitant 150 MG InjectionSCD1e6b36b2-3c8b-4ac4-827e-d6f00d9990322
1731077fosaprepitant 150 MG (as fosaprepitant dimeglumine 245.3 MG) InjectionSY1e6b36b2-3c8b-4ac4-827e-d6f00d9990322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72205-054-01722050054011 VIAL, SINGLE-DOSE in 1 CARTON (72205-054-01) / 5 mL in 1 VIAL, SINGLE-DOSE2020-05-120000-00-00NoNoCurrent