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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N216457-001APONVIEAPREPITANT32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-16

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N216457-001105002082035-09-18Drug product2022-10-05
N216457-001106248502035-09-18U-34402022-10-05
N216457-001109530182035-09-18U-34402022-10-05
N216457-001111731182035-09-18Drug product2022-10-05
N216457-001117448002035-09-18U-3690Drug product2023-10-02
N216457-001118780742035-09-18U-37872024-02-06
N216457-001121152542035-09-18Drug product2024-11-07
N216457-001121152552035-09-18Drug product2024-11-07
N216457-001122905202035-09-18Drug product2025-05-12
N216457-00195612292035-09-18U-3440Drug product2022-10-05
N216457-00198084652035-09-18U-34402022-10-05
N216457-00199747422035-09-18Drug product2022-10-05
N216457-00199747932035-09-18Drug product2022-10-05
N216457-00199747942035-09-18U-3440Drug product2022-10-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-168072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-16f41ea6bd6efb…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216457-001APONVIE32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUSRLD, RS2022-09-16a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 8 · 305 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N216457-001105002082035-09-18Drug product2022-10-05caaa826d4ba7…
2026-08-18 06:07:402026-07N216457-001106248502035-09-18U-34402022-10-05caaa826d4ba7…
2026-08-18 06:07:402026-07N216457-001109530182035-09-18U-34402022-10-05caaa826d4ba7…
2026-08-18 06:07:402026-07N216457-001111731182035-09-18Drug product2022-10-05caaa826d4ba7…
2026-08-18 06:07:402026-07N216457-001117448002035-09-18U-3690Drug product2023-10-02caaa826d4ba7…
2026-08-18 06:07:402026-07N216457-001118780742035-09-18U-37872024-02-06caaa826d4ba7…
2026-08-18 06:07:402026-07N216457-001121152542035-09-18Drug product2024-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N216457-001121152552035-09-18Drug product2024-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N216457-001122905202035-09-18Drug product2025-05-12caaa826d4ba7…
2026-08-18 06:07:402026-07N216457-00195612292035-09-18U-3440Drug product2022-10-05caaa826d4ba7…
2026-08-18 06:07:402026-07N216457-00198084652035-09-18U-34402022-10-05caaa826d4ba7…
2026-08-18 06:07:402026-07N216457-00199747422035-09-18Drug product2022-10-05caaa826d4ba7…
2026-08-18 06:07:402026-07N216457-00199747932035-09-18Drug product2022-10-05caaa826d4ba7…
2026-08-18 06:07:402026-07N216457-00199747942035-09-18U-3440Drug product2022-10-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216457-001105002082035-09-18Drug product2022-10-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216457-001106248502035-09-18U-34402022-10-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216457-001109530182035-09-18U-34402022-10-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216457-001111731182035-09-18Drug product2022-10-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216457-001117448002035-09-18U-3690Drug product2023-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216457-001118780742035-09-18U-37872024-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216457-001121152542035-09-18Drug product2024-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216457-001121152552035-09-18Drug product2024-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216457-001122905202035-09-18Drug product2025-05-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216457-00195612292035-09-18U-3440Drug product2022-10-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216457-00198084652035-09-18U-34402022-10-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216457-00199747422035-09-18Drug product2022-10-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216457-00199747932035-09-18Drug product2022-10-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216457-00199747942035-09-18U-3440Drug product2022-10-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216457-001105002082035-09-18Drug product2022-10-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216457-001106248502035-09-18U-34402022-10-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216457-001109530182035-09-18U-34402022-10-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216457-001111731182035-09-18Drug product2022-10-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216457-001117448002035-09-18U-3690Drug product2023-10-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216457-001118780742035-09-18U-37872024-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216457-001121152542035-09-18Drug product2024-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216457-001121152552035-09-18Drug product2024-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216457-001122905202035-09-18Drug product2025-05-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216457-00195612292035-09-18U-3440Drug product2022-10-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216457-00198084652035-09-18U-34402022-10-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216457-00199747422035-09-18Drug product2022-10-0531067a03dcf5…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1NF15YR6UYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2631783Internal RxNorm lookup
2631788Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d1b111eb-659a-496b-a86a-8f0fa370f147Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
APONVIEAPREPITANTHeron Therapeutics, Inc.d1b111eb-659a-496b-a86a-8f0fa370f1472026-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 216457
application number: NDA216457
ndc (product): 47426-401

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