FDA.reportPublic FDA data

PALONOSETRON

Product NDC
63323-673
11-digit product format
633230673
Labeler code
63323
Product ID
63323-673_a118bce3-a56b-4c7a-bb02-2c32abea5b0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Palonosetron
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA206802
Marketing category
ANDA
Marketing start
2018-09-19
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
A206802-001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206802-001AP

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 22:54:322026-06A206802-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206802-001AP1a50c72e98297…

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
PalonosetronPALONOSETRONFresenius Kabi USA, LLCb93fae8e-2b76-421e-95bc-ba08c211a7ea2021-01-11Warnings, Adverse reactionsExact identifier
ndc (product): 63323-673
PALONOSETRONPALONOSETRONFresenius Kabi USA, LLC9132366b-b808-46c9-b167-c1900bc116b32020-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206802
application number: ANDA206802
ndc (product): 63323-673

Additional Listing Data#

Finished product
Yes
Brand name base
PALONOSETRON
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
9132366b-b808-46c9-b167-c1900bc116b3Available 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
63323-673-21Palonosetron5 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION54
63323-673-89Palonosetron10 in 1 CARTONINJECTION, SOLUTION104
63323-673-05PALONOSETRON1 in 1 CARTONINJECTION, SOLUTION13
63323-673-05PALONOSETRON5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-673-05ML - Milliliter63323-6731a881bca-c760-420b-bb58-a2e84f05b36f12019-05-02
63323-673-21ML - Milliliter63323-673fe6a8d96-6355-4b62-b0b9-942e123c544a12018-10-11
63323-673-89ML - Milliliter63323-673a00c5a0f-c98a-4f8e-b108-e90b18bd410712018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-673PALONOSETRON INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 2 package rows20210204_b93fae8e-2b76-421e-95bc-ba08c211a7ea.zip
63323-673PALONOSETRON INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 2 package rows20210129_9132366b-b808-46c9-b167-c1900bc116b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2056929palonosetron 0.25 MG in 5 ML Prefilled SyringePSNb93fae8e-2b76-421e-95bc-ba08c211a7ea4
20569295 ML palonosetron 0.05 MG/ML Prefilled SyringeSCDb93fae8e-2b76-421e-95bc-ba08c211a7ea4
2056929palonosetron 0.25 MG in 5 ML Prefilled SyringeSYb93fae8e-2b76-421e-95bc-ba08c211a7ea4
1728055palonosetron 0.25 MG in 5 ML InjectionPSN9132366b-b808-46c9-b167-c1900bc116b33
17280555 ML palonosetron 0.05 MG/ML InjectionSCD9132366b-b808-46c9-b167-c1900bc116b33
1728055palonosetron 0.25 MG per 5 ML InjectionSY9132366b-b808-46c9-b167-c1900bc116b33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-673-05633230673051 VIAL, SINGLE-DOSE in 1 CARTON (63323-673-05) / 5 mL in 1 VIAL, SINGLE-DOSE2018-09-190000-00-00NoNoCurrent
63323-673-21633230673215 mL in 1 SYRINGE, PLASTIC5 mlHistorical
63323-673-896332306738910 SYRINGE, PLASTIC in 1 CARTON (63323-673-89) / 5 mL in 1 SYRINGE, PLASTIC (63323-673-21) 2018-09-190000-00-00NoNoCurrent