FDA.reportPublic FDA data

Palonosetron Hydrochloride

Product NDC
71288-409
11-digit product format
712880409
Labeler code
71288
Product ID
71288-409_a1f0c351-fcb5-4d19-94b1-3317b70be391
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Palonosetron Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA215861
Marketing category
ANDA
Marketing start
2023-08-14
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
A215861-001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2023-08-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215861-001AP

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 22:54:322026-06A215861-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2023-08-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A215861-001AP1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEMeitheal Pharmaceuticals Inc.11bb07b2-6530-45ab-a916-ba9dd3107fc32023-08-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215861
application number: ANDA215861
ndc (product): 71288-409

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
11bb07b2-6530-45ab-a916-ba9dd3107fc3Available 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
7746e9ce-fd27-4057-b741-9dd7c859eeeeProduct name120190219
1daa29fd-a861-43a1-a466-85dcbb6be7ecProduct name220180620
06499cfd-dc01-4a13-ac2b-7239d959d760Product name120180124
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-409-05Palonosetron Hydrochloride1 in 1 CARTONINJECTION, SOLUTION14
71288-409-05Palonosetron Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-409-05ML - Milliliter71288-4093954240c-82bf-46ca-8a24-65565fa2381312023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-409PALONOSETRON HYDROCHLORIDE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]4Current NDC, 2 package rows20230818_11bb07b2-6530-45ab-a916-ba9dd3107fc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1728055palonosetron 0.25 MG in 5 ML InjectionPSN11bb07b2-6530-45ab-a916-ba9dd3107fc34
17280555 ML palonosetron 0.05 MG/ML InjectionSCD11bb07b2-6530-45ab-a916-ba9dd3107fc34
1728055palonosetron 0.25 MG per 5 ML InjectionSY11bb07b2-6530-45ab-a916-ba9dd3107fc34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71288-409-05712880409051 VIAL, SINGLE-DOSE in 1 CARTON (71288-409-05) / 5 mL in 1 VIAL, SINGLE-DOSE2023-08-14NoNoCurrent