FDA.reportPublic FDA data

AKYNZEO

Product NDC
69639-102
11-digit product format
696390102
Labeler code
69639
Product ID
69639-102_4a6ba486-f8be-41a3-847e-429548867605
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosnetupitant and Palonosetron
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Helsinn Therapeutics (U.S.), Inc.
Application
NDA210493
Marketing category
NDA
Marketing start
2018-04-20
Substance
FOSNETUPITANT; PALONOSETRON HYDROCHLORIDE
Active strength
260; .28 mg/1; mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 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
AKYNZEO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSNETUPITANT260 mg/1
PALONOSETRON HYDROCHLORIDE.28 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii23310D4I19, 5D06587D6R, T672P80L2S, 7732P08TIR
Rxcui1552343, 1552349, 2044429, 2044431, 2374366, 2374368

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
69639-102-01AKYNZEO1 in 1 CARTONINJECTION118
69639-102-01AKYNZEO1 in 1 VIALINJECTION118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69639-102-01EA - Each69639-102bee161b6-a44a-445d-ba8f-3dbe64e3f3ee12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69639-102AKYNZEO (NETUPITANT AND PALONOSETRON) CAPSULE AKYNZEO (FOSNETUPITANT AND PALONOSETRON) INJECTION [HELSINN THERAPEUTICS (U.S.), INC.]16Current NDC, Legacy NDC, 2 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
69639-102-01696390102011 VIAL in 1 CARTON (69639-102-01) / 1 INJECTION in 1 VIAL1 vial2018-04-200000-00-00NoNoCurrent