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

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
A202521-001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2015-10-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A202521-001AP

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 22:54:322026-06A202521-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2015-10-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202521-001AP1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDESandoz Inc5bfb3984-2b47-4e06-9bbb-d055ebc376c82024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202521
application number: ANDA202521
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDESandoz Incaff1505c-8d34-46e6-9559-c5b1128878752024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202521
application number: ANDA202521
ndc (product): 0781-3312

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
23310D4I19Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1728055Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aff1505c-8d34-46e6-9559-c5b112887875Available 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
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-DOSE2024-10-01NoNoCurrent