FDA.reportPublic FDA data

AKYNZEO

Product NDC
69639-101
11-digit product format
696390101
Labeler code
69639
Product ID
69639-101_4a6ba486-f8be-41a3-847e-429548867605
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Netupitant and Palonosetron
Dosage form
CAPSULE
Route
ORAL
Labeler
Helsinn Therapeutics (U.S.), Inc.
Application
NDA205718
Marketing category
NDA
Marketing start
2014-10-13
Substance
NETUPITANT; PALONOSETRON
Active strength
300; .5 mg/1; mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], P-Glycoprotein Inhibitors [MoA], Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC], 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 1.

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
N205718-001AKYNZEONETUPITANT; PALONOSETRON HYDROCHLORIDE300MG;EQ 0.5MG BASECAPSULE / ORALRLD, RS2014-10-10

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205718-001115595232030-11-18U-3522Drug product2023-02-22
N205718-001120424942030-11-18U-3522Drug product2024-08-07
N205718-00186238262030-11-18U-22932014-11-06
N205718-00189519692030-11-18Drug product2015-03-06
N205718-00191863572030-11-18U-22932015-12-02
N205718-00199435152030-11-18U-22932018-05-16
N205718-001108282972030-12-17U-22932020-12-04
N205718-00192719752031-09-09U-22932016-07-14
N205718-001102331542035-09-25Drug substance2019-03-28
N205718-001106764402035-09-25Drug substance, Drug product2020-07-08
N205718-001109611952035-09-25Drug substance, Drug product2021-04-15
N205718-00199510162035-09-25Drug substance, Drug product2018-05-16

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
2026-08-01 22:54:322026-06N205718-001AKYNZEO300MG;EQ 0.5MG BASECAPSULE / ORALRLD, RS2014-10-10a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N205718-001115595232030-11-18U-3522Drug product2023-02-22a50c72e98297…
2026-08-01 22:54:322026-06N205718-001120424942030-11-18U-3522Drug product2024-08-07a50c72e98297…
2026-08-01 22:54:322026-06N205718-00186238262030-11-18U-22932014-11-06a50c72e98297…
2026-08-01 22:54:322026-06N205718-00189519692030-11-18Drug product2015-03-06a50c72e98297…
2026-08-01 22:54:322026-06N205718-00191863572030-11-18U-22932015-12-02a50c72e98297…
2026-08-01 22:54:322026-06N205718-00199435152030-11-18U-22932018-05-16a50c72e98297…
2026-08-01 22:54:322026-06N205718-001108282972030-12-17U-22932020-12-04a50c72e98297…
2026-08-01 22:54:322026-06N205718-00192719752031-09-09U-22932016-07-14a50c72e98297…
2026-08-01 22:54:322026-06N205718-001102331542035-09-25Drug substance2019-03-28a50c72e98297…
2026-08-01 22:54:322026-06N205718-001106764402035-09-25Drug substance, Drug product2020-07-08a50c72e98297…
2026-08-01 22:54:322026-06N205718-001109611952035-09-25Drug substance, Drug product2021-04-15a50c72e98297…
2026-08-01 22:54:322026-06N205718-00199510162035-09-25Drug substance, Drug product2018-05-16a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AKYNZEONETUPITANT AND PALONOSETRONHelsinn Therapeutics (U.S.), Inc.8e47618e-af46-4d82-94e8-1507c042252d2026-06-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 205718
application number: NDA205718
ndc (product): 69639-101

Additional Listing Data#

Finished product
Yes
Brand name base
AKYNZEO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NETUPITANT300 mg/1
PALONOSETRON.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
23310D4I19Internal UNII lookup
7732P08TIRInternal UNII lookup
T672P80L2SInternal UNII lookup
5D06587D6RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1552343Internal RxNorm lookup
1552349Internal RxNorm lookup
2044429Internal RxNorm lookup
2044431Internal RxNorm lookup
2374366Internal RxNorm lookup
2374368Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8e47618e-af46-4d82-94e8-1507c042252dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
61b26fe6-497b-4f61-a1b1-af738421df7eProduct name120260128
bcdb3cc7-59df-d946-62ec-4c975de6d4f2Product name920241009
7746e9ce-fd27-4057-b741-9dd7c859eeeeProduct name120190219
1daa29fd-a861-43a1-a466-85dcbb6be7ecProduct name220180620
06499cfd-dc01-4a13-ac2b-7239d959d760Product name120180124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69639-101-01AKYNZEO1 in 1 CARTONCAPSULE118
69639-101-01AKYNZEO1 in 1 BLISTER PACKCAPSULE118
69639-101-04AKYNZEO2 in 1 BLISTER PACKCAPSULE218
69639-101-04AKYNZEO2 in 1 CARTONCAPSULE218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69639-101-01EA - Each69639-10198349ee9-b985-4fd2-ba3c-cd1ba73d27df12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69639-101AKYNZEO (NETUPITANT AND PALONOSETRON) CAPSULE AKYNZEO (FOSNETUPITANT AND PALONOSETRON) INJECTION [HELSINN THERAPEUTICS (U.S.), INC.]16Current NDC, Legacy NDC, 4 package rows20231205_8e47618e-af46-4d82-94e8-1507c042252d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2374368Akynzeo 235 MG / 0.25 MG in 20 ML InjectionPSN8e47618e-af46-4d82-94e8-1507c042252d18
2044431Akynzeo 235 MG / 0.25 MG InjectionPSN8e47618e-af46-4d82-94e8-1507c042252d18
1552349Akynzeo 300 MG / 0.5 MG Oral CapsulePSN8e47618e-af46-4d82-94e8-1507c042252d18
2374366fosnetupitant 235 MG / palonosetron 0.25 MG in 20 ML InjectionPSN8e47618e-af46-4d82-94e8-1507c042252d18
2044429fosnetupitant 235 MG / palonosetron 0.25 MG InjectionPSN8e47618e-af46-4d82-94e8-1507c042252d18
1552343netupitant 300 MG / palonosetron 0.5 MG Oral CapsulePSN8e47618e-af46-4d82-94e8-1507c042252d18
237436820 ML fosnetupitant 11.75 MG/ML / palonosetron 0.0125 MG/ML Injection [Akynzeo]SBD8e47618e-af46-4d82-94e8-1507c042252d18
2044431fosnetupitant 235 MG / palonosetron 0.25 MG Injection [Akynzeo]SBD8e47618e-af46-4d82-94e8-1507c042252d18
1552349netupitant 300 MG / palonosetron 0.5 MG Oral Capsule [Akynzeo]SBD8e47618e-af46-4d82-94e8-1507c042252d18
237436620 ML fosnetupitant 11.75 MG/ML / palonosetron 0.0125 MG/ML InjectionSCD8e47618e-af46-4d82-94e8-1507c042252d18
2044429fosnetupitant 235 MG / palonosetron 0.25 MG InjectionSCD8e47618e-af46-4d82-94e8-1507c042252d18
1552343netupitant 300 MG / palonosetron 0.5 MG Oral CapsuleSCD8e47618e-af46-4d82-94e8-1507c042252d18
2374368Akynzeo (fosnetupitant 235 MG (equivalent to fosnetupitant chloride HCl 260 MG) / palonosetron 0.25 MG (equivalent to palonosetron HCl 28 MG)) per 20 ML InjectionSY8e47618e-af46-4d82-94e8-1507c042252d18
2044431Akynzeo (fosnetupitant 235 MG / palonosetron 0.25 MG) InjectionSY8e47618e-af46-4d82-94e8-1507c042252d18
1552349Akynzeo (netupitant 300 MG / palonosetron 0.5 MG (palonosetron hydrochloride 0.56 MG)) Oral CapsuleSY8e47618e-af46-4d82-94e8-1507c042252d18
1552349Akynzeo (netupitant 300 MG / palonosetron 0.5) MG Oral CapsuleSY8e47618e-af46-4d82-94e8-1507c042252d18
2374366fosnetupitant 235 MG (equivalent to fosnetupitant chloride HCl 260 MG) / palonosetron 0.25 MG (equivalent to palonosetron HCl 28 MG) per 20 ML InjectionSY8e47618e-af46-4d82-94e8-1507c042252d18
2374366fosnetupitant 235 MG / palonosetron 0.25 MG per 20 ML InjectionSY8e47618e-af46-4d82-94e8-1507c042252d18
1552343netupitant 300 MG / palonosetron 0.5 MG (as palonosetron hydrochloride 0.56 MG) Oral CapsuleSY8e47618e-af46-4d82-94e8-1507c042252d18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69639-101-01696390101011 BLISTER PACK in 1 CARTON (69639-101-01) / 1 CAPSULE in 1 BLISTER PACK1 blister pack2014-10-130000-00-00NoNoCurrent
69639-101-04696390101042 BLISTER PACK in 1 CARTON (69639-101-04) / 2 CAPSULE in 1 BLISTER PACK2 blister pack2014-10-130000-00-00NoNoCurrent