FDA.reportPublic FDA data

NDC 44087-4000-04 - Mavenclad

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
44087-4000
Requested NDC
44087-4000-04
Package NDCs from labels
44087-4000-4, 44087-4000-5, 44087-4000-6, 44087-4000-7, 44087-4000-8, 44087-4000-9, 44087-4000-0, 44087-4000-04
Manufacturer
EMD Serono, Inc. | R-Pharm Germany GmbH
Effective date
2026-05-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mavenclad - EMD Serono, Inc. | R-Pharm Germany GmbHEMD Serono, Inc. | R-Pharm Germany GmbH2026-05-27HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
44087-4000-02024-01-30These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-42024-01-30These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-52024-01-30These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-62024-01-30These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-72024-01-30These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-82024-01-30These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-92024-01-30These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-02022-02-02These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-42022-02-02These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-52022-02-02These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-62022-02-02These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-72022-02-02These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-82022-02-02These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-92022-02-02These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-02022-01-28These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-42022-01-28These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-52022-01-28These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-62022-01-28These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-72022-01-28These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-82022-01-28These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-92022-01-28These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44087-4000-0Mavenclad2 in 1 BLISTER PACKTABLET210
44087-4000-0Mavenclad5 in 1 CARTONTABLET510
44087-4000-4Mavenclad1 in 1 BLISTER PACKTABLET110
44087-4000-4Mavenclad4 in 1 CARTONTABLET410
44087-4000-5Mavenclad1 in 1 BLISTER PACKTABLET110
44087-4000-5Mavenclad5 in 1 CARTONTABLET510
44087-4000-6Mavenclad6 in 1 CARTONTABLET610
44087-4000-6Mavenclad1 in 1 BLISTER PACKTABLET110
44087-4000-7Mavenclad1 in 1 BLISTER PACKTABLET110
44087-4000-7Mavenclad7 in 1 CARTONTABLET710
44087-4000-8Mavenclad1 in 1 BLISTER PACKTABLET110
44087-4000-8Mavenclad8 in 1 CARTONTABLET810
44087-4000-9Mavenclad1 in 1 BLISTER PACKTABLET110
44087-4000-9Mavenclad9 in 1 CARTONTABLET910

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44087-4000MAVENCLAD (CLADRIBINE) TABLET [EMD SERONO, INC.]8Current NDC, Legacy NDC, 14 package rows20240523_9c75e30a-a410-40f1-b653-04d532bd9144.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44087-4000-0EA - Each44087-400072629d0a-cb99-46d3-a443-715cd568936812019-06-19
44087-4000-4EA - Each44087-4000cfa9f57c-b38b-4f9e-9379-3e1484bad8cb12019-06-19
44087-4000-5EA - Each44087-4000ac773474-25f7-4eb0-9141-ba11f361dde112019-06-19
44087-4000-6EA - Each44087-4000ec00c72a-f05e-4b79-8c9c-04799d91e5bd12019-06-19
44087-4000-7EA - Each44087-4000f261a4cd-786d-44ec-b355-b3d05a2e638712019-06-19
44087-4000-8EA - Each44087-4000c769fb6c-e76c-4e9a-81d2-3087ca8ec63512019-06-19
44087-4000-9EA - Each44087-4000032a40c8-0228-44f8-baf2-1288d3acd8a712019-06-19

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: 506T60A25R
CladribineCLADRIBINESandoz Inc.e0b363cb-db83-44d6-89d0-1f7176be74592026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2122658
rxcui: 2122649
rxcui: 2122647
rxcui: 2122635
rxcui: 2122660
rxcui: 2122654
rxcui: 2122656
rxcui: 2122634
unii: 47M74X9YT5
CladribineCLADRIBINEApotex Corp.407c52d5-6498-7da5-da35-acc9ca73ced32026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2122658
rxcui: 2122649
rxcui: 2122647
rxcui: 2122635
rxcui: 2122660
rxcui: 2122654
rxcui: 2122656
rxcui: 2122634
unii: 47M74X9YT5
MavencladCLADRIBINEEMD Serono, Inc.9c75e30a-a410-40f1-b653-04d532bd91442026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA022561
ndc (package): 44087-4000-6
ndc (package): 44087-4000-9
ndc (package): 44087-4000-7
ndc (package): 44087-4000-8
ndc (package): 44087-4000-0
ndc (package): 44087-4000-5
ndc (package): 44087-4000-4
ndc (product): 44087-4000
ndc11 (package): 44087400004
rxcui: 2122658
rxcui: 2122649
rxcui: 2122648
rxcui: 2122647
rxcui: 2122661
rxcui: 2122657
rxcui: 2122635
rxcui: 2122660
rxcui: 2122654
rxcui: 2122656
rxcui: 2122634
rxcui: 2122659
rxcui: 2122650
rxcui: 2122655
rxcui: 2122642
rxcui: 2122641
spl id: c9ed888a-183b-45e9-9274-08aad408e926
spl set id: 9c75e30a-a410-40f1-b653-04d532bd9144
unii: 47M74X9YT5
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: 506T60A25R
GeriCare Sorbitol SolutionSORBITOLGERI-CARE PHARMACEUTICALS, CORPb4dd7a41-380e-d94b-e053-2a95a90ac34a2025-12-31WarningsExact identifier
unii: 506T60A25R
CladribineCLADRIBINEHisun Pharmaceuticals USA, Inc.71c39b37-33b5-42e1-bf4f-93ff751cc7fe2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 47M74X9YT5
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: 506T60A25R
CladribineCLADRIBINEGenvion Corporationf1d650a5-4205-720b-f39b-4213277b66122025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2122658
rxcui: 2122649
rxcui: 2122647
rxcui: 2122635
rxcui: 2122660
rxcui: 2122654
rxcui: 2122656
rxcui: 2122634
unii: 47M74X9YT5
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 506T60A25R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 506T60A25R
CladribineCLADRIBINEHisun Pharmaceuticals USA, Inc.f538cba9-001a-4a21-e053-2a95a90a00ec2025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 47M74X9YT5
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: 506T60A25R
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: 506T60A25R
CladribineCLADRIBINEFresenius Kabi USA, LLCa2592a9b-bca6-4a5a-89c2-855a0634d5fe2024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 47M74X9YT5
ChemtoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, HEPAR SUIS, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARSENICUM ALBUM, ASARUM CANADENSE, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, SELENIUM METALLICUM, SULPHURICUM ACIDUM, CHLORINUM, BUTYLBENZENE, PETROLEUM, SORBITOLDeseret Biologicals, Inc.91f52c95-f36d-4754-8570-f81ed8d361802024-03-06WarningsExact identifier
unii: 506T60A25R
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
CladribineCLADRIBINEHikma Pharmaceuticals USA Inc.5736aecc-cc1d-47dd-86c0-5fb2e9d70f612023-04-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 47M74X9YT5
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

Reported adverse events (FAERS/openFDA)#

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