FDA.reportPublic FDA data

NDC 63323-762-17 - Topotecan Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63323-762
Requested NDC
63323-762-17
Package NDCs from labels
63323-762-10, 63323-762-94, 63323-762-17
Manufacturer
Fresenius Kabi USA, LLC | ScinoPharm Taiwan, Ltd.
Effective date
2026-01-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Topotecan Hydrochloride - Fresenius Kabi USA, LLC | ScinoPharm Taiwan, Ltd.Fresenius Kabi USA, LLC | ScinoPharm Taiwan, Ltd.2026-01-14HUMAN PRESCRIPTION DRUG LABEL
Topotecan Hydrochloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-11-27HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-762-10Topotecan Hydrochloride1 in 1 BOXINJECTION, POWDER, LYOPHILIZED,115
63323-762-10Topotecan Hydrochloride4 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,415

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-762TOPOTECAN HYDROCHLORIDE (TOPOTECAN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]14Current NDC, Legacy NDC, 2 package rows20240724_b6019088-cd94-43b4-b5ce-ba20b6b8021e.zip
63323-762TOPOTECAN HYDROCHLORIDE (TOPOTECAN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC20210626_b094e6ba-7cf6-4fb8-8683-73d324650dd3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-762-10EA - Each63323-7621018eb56-e99d-4b4f-b87f-c915aecdf76b12013-02-13
63323-762-17EA - Each63323-762723c6eb3-565a-46be-9f37-694c0d613cdc12013-02-13
63323-762-94EA - Each63323-762a90264b3-9d81-424e-90c6-05d7165e258312013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPOTECAN HYDROCHLORIDEACTIVE INGREDIENT956S425ZCYTOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
TOPOTECANACTIVE MOIETY7M7YKX2N15TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBTOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ATOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HTOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
8e14e597-acf1-4799-a419-397d311ecce0b094e6ba-7cf6-4fb8-8683-73d324650dd32026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: b094e6ba-7cf6-4fb8-8683-73d324650dd3
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Joint Tonic R IIHARPAGOPHYTUM PROCUMBENS, SALIX ALBA, COLCHICUM AUTUMNALE, PINUS SYLVESTRIS, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARNICA MONTANA, GELSEMIUM SEMPERVIRENS, IRIS VERSICOLOR, LEDUM PALUSTRE, LESPEDEZA CAPITATA, RHUS TOX, SECALE CORNUTUM, SPIGELIA ANTHELMIA, SPIRAEA ULMARIA, TARTARICUM ACIDUMBioActive Nutritional, Inc.77afccf5-4e9c-45a1-8a6a-e686bcf22f162026-04-17WarningsExact identifier
unii: W4888I119H
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: QTT17582CB
Topotecan HydrochlorideTOPOTECAN HYDROCHLORIDEFresenius Kabi USA, LLCb6019088-cd94-43b4-b5ce-ba20b6b8021e2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA091089
ndc (package): 63323-762-10
ndc (product): 63323-762
rxcui: 1799416
spl id: 7f91362f-6b55-4518-b034-b54aa5881204
spl set id: b6019088-cd94-43b4-b5ce-ba20b6b8021e
unii: 956S425ZCY
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: W4888I119H
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Bestmade Natural Products BM182 PelletsGRAPHITES, HEPAR SULF, MERC SOL, MURIATIC ACIDBestmade Natural Products3242e013-2952-2b56-e063-6294a90a16932025-04-08WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.