FDA.reportPublic FDA data

Palonosetron hydrochloride

Product NDC
69097-439
11-digit product format
690970439
Labeler code
69097
Product ID
69097-439_6d581638-ccce-4326-b306-e1e6372979aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Palonsetron hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Cipla USA Inc.
Application
ANDA206396
Marketing category
ANDA
Marketing start
2021-10-10
Marketing end
0000-00-00
Substance
PALONOSETRON HYDROCHLORIDE
Active strength
0 mg/5mL
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69097-439DDiscontinued by firm2026-07-31
excluded packagepackage69097-43969097-439-35DDiscontinued by firm2026-07-31

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
A206396-001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19

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 22:54:322026-06A206396-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-439-35ML - Milliliter69097-439ed1f58af-81ec-4f17-8024-64097f466c6012019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-439-35690970439351 VIAL, SINGLE-USE in 1 CARTON (69097-439-35) > 5 mL in 1 VIAL, SINGLE-USE2019-03-250000-00-00NoNoCurrent