FDA.reportPublic FDA data

Palonosetron Hydrochloride

Product NDC
0781-3312
11-digit product format
007813312
Labeler code
0781
Product ID
0781-3312_efda8bac-8bb7-4e4c-b4f4-6bc540247a80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Palonosetron Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA202521
Marketing category
ANDA
Marketing start
2018-03-23
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
Palonosetron Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii23310D4I19
Rxcui1728055

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
0781-3312-75Palonosetron Hydrochloride1 in 1 CARTONINJECTION, SOLUTION123
0781-3312-75Palonosetron Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION523
0781-3312-95Palonosetron Hydrochloride10 in 1 CARTONINJECTION, SOLUTION1023
0781-3312-95Palonosetron Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION523

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3312-75ML - Milliliter0781-3312985fcd06-9a3e-4fd6-a3f6-f4414f66823c12018-04-19
0781-3312-95ML - Milliliter0781-3312c060514b-f018-440d-bcf2-9f9c0205e7e312024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3312PALONOSETRON HYDROCHLORIDE INJECTION, SOLUTION [SANDOZ INC]23Current NDC, Legacy NDC, 4 package rows20240823_aff1505c-8d34-46e6-9559-c5b112887875.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1728055palonosetron 0.25 MG in 5 ML InjectionPSNaff1505c-8d34-46e6-9559-c5b11288787523
17280555 ML palonosetron 0.05 MG/ML InjectionSCDaff1505c-8d34-46e6-9559-c5b11288787523
1728055palonosetron 0.25 MG per 5 ML InjectionSYaff1505c-8d34-46e6-9559-c5b11288787523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3312-75007813312751 VIAL, SINGLE-DOSE in 1 CARTON (0781-3312-75) / 5 mL in 1 VIAL, SINGLE-DOSE2018-03-230000-00-00NoNoCurrent
0781-3312-950078133129510 VIAL, SINGLE-DOSE in 1 CARTON (0781-3312-95) / 5 mL in 1 VIAL, SINGLE-DOSE2024-10-01NoNoHistorical