FDA.reportPublic FDA data

posfrea

Product NDC
83831-105
11-digit product format
838310105
Labeler code
83831
Product ID
83831-105_2f9cbcbc-86ee-49e4-a98a-d7fa286a32b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
palonosetron
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Avyxa Pharma, LLC
Application
NDA203050
Marketing category
NDA
Marketing start
2024-09-30
Substance
PALONOSETRON HYDROCHLORIDE
Active strength
.25 mg/5mL
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 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
posfrea
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PALONOSETRON HYDROCHLORIDE.25 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii23310D4I19
Rxcui1728050, 1728055, 2688837, 2688839

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
61b26fe6-497b-4f61-a1b1-af738421df7eProduct name120260128
bcdb3cc7-59df-d946-62ec-4c975de6d4f2Product name920241009
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
7746e9ce-fd27-4057-b741-9dd7c859eeeeProduct name120190219
1daa29fd-a861-43a1-a466-85dcbb6be7ecProduct name220180620
06499cfd-dc01-4a13-ac2b-7239d959d760Product name120180124
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83831-105-01posfrea1 in 1 CARTONINJECTION, SOLUTION17
83831-105-01posfrea5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83831-105-01ML - Milliliter83831-105ed6bb053-27cb-4596-b4d9-182b68b57cca12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83831-105POSFREA (PALONOSETRON) INJECTION, SOLUTION [AVYXA PHARMA, LLC]7Current NDC, 2 package rows20250430_13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1728050palonosetron 0.075 MG in 1.5 ML InjectionPSN13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a77
1728055palonosetron 0.25 MG in 5 ML InjectionPSN13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a77
2688837Posfrea 0.075 MG in 1.5 ML InjectionPSN13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a77
2688839Posfrea 0.25 MG in 5 ML InjectionPSN13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a77
26888371.5 ML palonosetron 0.05 MG/ML Injection [Posfrea]SBD13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a77
26888395 ML palonosetron 0.05 MG/ML Injection [Posfrea]SBD13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a77
17280501.5 ML palonosetron 0.05 MG/ML InjectionSCD13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a77
17280555 ML palonosetron 0.05 MG/ML InjectionSCD13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a77
1728050palonosetron 0.075 MG per 1.5 ML InjectionSY13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a77
1728055palonosetron 0.25 MG per 5 ML InjectionSY13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a77
2688837Posfrea 0.075 MG per 1.5 ML InjectionSY13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a77
2688839Posfrea 0.25 MG per 5 ML InjectionSY13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83831-105-01838310105011 VIAL, SINGLE-DOSE in 1 CARTON (83831-105-01) / 5 mL in 1 VIAL, SINGLE-DOSE2024-09-30NoNoCurrent