FDA.reportPublic FDA data

NDC 59751-087 - IRINOTECAN 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
59751-087
Package NDCs from labels
59751-087-30, 59751-087-31
Manufacturer
Intas Pharmaceuticals | Intas Pharmaceuticals Limited
Effective date
2023-12-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IRINOTECAN HYDROCHLORIDE - Intas Pharmaceuticals | Intas Pharmaceuticals LimitedIntas Pharmaceuticals | Intas Pharmaceuticals Limited2023-12-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59751-087-30IRINOTECAN HYDROCHLORIDE1 in 1 CARTONINJECTION13
59751-087-30IRINOTECAN HYDROCHLORIDE2 mL in 1 VIAL, SINGLE-DOSEINJECTION23
59751-087-31IRINOTECAN HYDROCHLORIDE1 in 1 CARTONINJECTION13
59751-087-31IRINOTECAN HYDROCHLORIDE5 mL in 1 VIAL, SINGLE-DOSEINJECTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59751-087IRINOTECAN HYDROCHLORIDE INJECTION [INTAS PHARMACEUTICALS]34 package rows20240101_aa6f03e2-2c4e-43e9-9975-102ef199029e.zip

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 4 of 4 · 80 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: 506T60A25R
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: 506T60A25R
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 33X04XA5AT
PancreaparSYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUMEnergique, Inc.ba9c13d0-92de-4159-8a35-215e3de50c072023-08-24WarningsExact identifier
unii: 33X04XA5AT
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREATINUM, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.2fe2d3c1-1829-4a33-be8e-2bad52546f362023-07-17WarningsExact identifier
unii: QTT17582CB
Irinotecan HydrochlorideIRINOTECAN HYDROCHLORIDEFresenius Kabi USA, LLCee45f127-8450-4455-a945-a1f5707f1d392023-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1726319
rxcui: 1726324
unii: 042LAQ1IIS
Acidum MuriaticumACIDUM MURIATICUMHahnemann Laboratories, INC.f2aad04c-5151-6cab-e053-2a95a90ad3a72023-01-19Exact identifier
unii: QTT17582CB
ChemDetoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUMDr. Donna Restivo DC2a17f80d-12c0-43a0-980b-9da648e9b76a2023-01-10WarningsExact identifier
unii: 506T60A25R
Irinotecan hydrochlorideIRINOTECAN HYDROCHLORIDENorthstar Rx LLC4f98e9ed-f7b1-5346-af72-fccb0abf3f4b2022-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1726319
rxcui: 1726324
unii: 042LAQ1IIS
Irinotecan hydrochloideIRINOTECAN HYDROCHLOIDEGland Pharma Limitedde634e80-328a-4473-b395-0172683a24112022-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1726319
rxcui: 1726324
unii: 042LAQ1IIS
BHI HemorrhoidHORSE CHESTNUT, ALOE, COLLINSONIA CANADENSIS ROOT, VERONICASTRUM VIRGINICUM ROOT, HYDROCHLORIC ACID, STRYCHNOS NUX-VOMICA SEED, PAEONIA OFFICINALIS ROOT, AND SULFURMediNatura Incd7df7d3e-48ad-4f58-aef5-a7bd48d2f1912022-01-05WarningsExact identifier
unii: QTT17582CB
Joette Calabrese Survivalist KitABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIPOHM PHARMA INC.1ac2a2c4-704e-4efa-aa44-acc71d300f702021-12-29WarningsExact identifier
unii: QTT17582CB
FungisodeARSENICUM ALBUM, BERBERIS VULGARIS, CALCAREA CARBONICA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NITRICUM ACIDUM, OXALICUM ACIDUM, SEPIA OFFICINALIS, SULPHURSeroyal USA55c5dfc4-3757-6ac2-e054-00144ff88e882021-07-22WarningsExact identifier
unii: QTT17582CB
Irinotecan HydrochlorideIRINOTECAN HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.afcdde49-ec0c-4c56-a1af-2917185b1a082021-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1726319
rxcui: 1726324
unii: 042LAQ1IIS
Irinotecan HydrochlorideIRINOTECAN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.9c6aa884-750e-4b11-9955-bc7ab6e9c2ad2020-06-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1726324
unii: 042LAQ1IIS
Irinotecan HydrochlorideIRINOTECAN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.be716692-6b4f-47b6-83d1-01665861626b2020-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1726319
rxcui: 1726324
unii: 042LAQ1IIS
SorbitolSORBITOLBaxter Healthcare Corporationaea0b5a1-444b-4330-a3ce-26485dbbfe752019-12-31Warnings, Adverse reactionsExact identifier
unii: 506T60A25R
OMEOSPORT.ALPHA.-KETOGLUTARIC ACID - ACONITIC ACID, CIS - ADENOSINE TRIPHOSPHATE - ALPHA LIPOIC ACID - ASCORBIC ACID - ASIAN GINSENG - BARIUM CATION - BEET - CEROUS OXALATE NONAHYDRATE - COENZYME A - CYSTEINE - FUMARIC ACID - LACTIC ACID, DL - MAGNESIUM CARBONATE - MALIC ACID - MANGANESE PHOSPHATE, DIBASIC - PORK - PYRIDOXINE HYDROCHLORIDE - RIBOFLAVIN - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SUCCINIC ACID - SUS SCROFA ADRENAL GLAND - THIAMINE HYDROCHLORIDE - SUS SCROFA EMBRYO -Guna spa119a205d-0074-48ff-ac78-e2300db452272018-12-21WarningsExact identifier
unii: 33X04XA5AT
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: 506T60A25R
Glucose Control T015SYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUMGuangzhou Renuma Medical Systems Co., Ltd3fd02c0a-5cf1-4f35-86d0-d5d09e63f39b2017-10-26WarningsExact identifier
unii: 33X04XA5AT

Reported adverse events (FAERS/openFDA)#

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