FDA.reportPublic FDA data

Fosaprepitant

Product NDC
68001-523
11-digit product format
680010523
Labeler code
68001
Product ID
68001-523_38efdfbe-c95c-1be8-e063-6394a90abdda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosaprepitant dimeglumine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA214616
Marketing category
ANDA
Marketing start
2022-02-02
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
68001-523-36Fosaprepitant1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15
68001-523-36Fosaprepitant5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-523-36EA - Each68001-5235a1b3121-f112-4a33-b436-8a1e2365ea6612022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-523FOSAPREPITANT (FOSAPREPITANT DIMEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BLUEPOINT LABORATORIES]4Current NDC, Legacy NDC, 2 package rows20230413_2d30d839-bb88-46ce-a9ed-66fe32a12a7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731077fosaprepitant 150 MG InjectionPSN2d30d839-bb88-46ce-a9ed-66fe32a12a7a5
1731077fosaprepitant 150 MG InjectionSCD2d30d839-bb88-46ce-a9ed-66fe32a12a7a5
1731077fosaprepitant 150 MG (as fosaprepitant dimeglumine 245.3 MG) InjectionSY2d30d839-bb88-46ce-a9ed-66fe32a12a7a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-523-36680010523361 VIAL, SINGLE-DOSE in 1 CARTON (68001-523-36) / 5 mL in 1 VIAL, SINGLE-DOSE2022-02-020000-00-00NoNoCurrent