FDA.reportPublic FDA data

APONVIE

Product NDC
47426-401
11-digit product format
474260401
Labeler code
47426
Product ID
47426-401_aeb8e76c-6054-4324-8f4f-bfdcf9ce4856
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
APREPITANT
Dosage form
EMULSION
Route
INTRAVENOUS
Labeler
Heron Therapeutics, Inc.
Application
NDA216457
Marketing category
NDA
Marketing start
2023-03-06
Substance
APREPITANT
Active strength
32 mg/4.4mL
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
APONVIE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APREPITANT32 mg/4.4mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1NF15YR6UY
Rxcui2631783, 2631788

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
9f9a82fd-fcee-442f-9233-7f2d2f9f4568Product name120180108
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47426-401-01APONVIE4.4 mL in 1 VIAL, GLASSEMULSION4.48
47426-401-10APONVIE10 in 1 CARTONEMULSION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47426-401-01ML - Milliliter47426-401027123ac-c396-4c45-9a3e-d6009a74317b12022-12-07
47426-401-10ML - Milliliter47426-4019c8063b5-7dbe-4a29-a2e1-031d20b1832412022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47426-401APONVIE (APREPITANT) EMULSION [HERON THERAPEUTICS, INC.]5Current NDC, 2 package rows20240319_d1b111eb-659a-496b-a86a-8f0fa370f147.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2631788APONVIE 32 MG in 4.4 ML InjectionPSNd1b111eb-659a-496b-a86a-8f0fa370f1478
2631783aprepitant 32 MG in 4.4 ML InjectionPSNd1b111eb-659a-496b-a86a-8f0fa370f1478
26317884.4 ML aprepitant 7.2 MG/ML Injection [Aponvie]SBDd1b111eb-659a-496b-a86a-8f0fa370f1478
26317834.4 ML aprepitant 7.2 MG/ML InjectionSCDd1b111eb-659a-496b-a86a-8f0fa370f1478
26317884.4 ML Aponvie 7.2 MG/ML InjectionSYd1b111eb-659a-496b-a86a-8f0fa370f1478
2631788Aponvie 32 MG per 4.4 ML InjectionSYd1b111eb-659a-496b-a86a-8f0fa370f1478
2631783aprepitant 32 MG per 4.4 ML InjectionSYd1b111eb-659a-496b-a86a-8f0fa370f1478

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
47426-401-01474260401014.4 mL in 1 VIAL, GLASS4.4 mlHistorical
47426-401-104742604011010 VIAL, GLASS in 1 CARTON (47426-401-10) / 4.4 mL in 1 VIAL, GLASS (47426-401-01) 2023-03-06NoNoCurrent