FDA.reportPublic FDA data

Mavenclad

Product NDC
44087-4000
11-digit product format
440874000
Labeler code
44087
Product ID
44087-4000_4f6e2bce-df90-4b30-a969-59810b302b52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cladribine
Dosage form
TABLET
Route
ORAL
Labeler
EMD Serono, Inc.
Application
NDA022561
Marketing category
NDA
Marketing start
2019-04-01
Substance
CLADRIBINE
Active strength
10 mg/1
Pharmacologic classes
Purine Antimetabolite [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mavenclad
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLADRIBINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii47M74X9YT5
Rxcui2122634, 2122635, 2122641, 2122642, 2122647, 2122648, 2122649, 2122650, 2122654, 2122655, 2122656, 2122657, 2122658, 2122659, 2122660, 2122661

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e6341a9e-3b90-6d63-7529-e3c0b6be164aProduct name220200511
21075a88-376d-46da-a075-a9797650ce34Product name120190702

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44087-4000-02024-01-30C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-42024-01-30C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-52024-01-30C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-62024-01-30C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-72024-01-30C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-82024-01-30C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-92024-01-30C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-02022-02-02C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-42022-02-02C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-52022-02-02C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-62022-02-02C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-72022-02-02C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-82022-02-02C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-92022-02-02C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-02022-01-28C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-42022-01-28C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-52022-01-28C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-62022-01-28C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-72022-01-28C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-82022-01-28C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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
44087-4000-92022-01-28C16284748780-1d6a99b39-849b-a426-e053-dadaa90af4c2These 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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2122661{10 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 10 Tablet Pack]BPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122659{4 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 4 Tablet Pack]BPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122657{5 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 5 Tablet Pack]BPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122655{6 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 6 Tablet Pack]BPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122650{7 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 7 Tablet Pack]BPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122648{8 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 8 Tablet Pack]BPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122642{9 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 9 Tablet Pack]BPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122660{10 (cladribine 10 MG Oral Tablet) } PackGPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122658{4 (cladribine 10 MG Oral Tablet) } PackGPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122656{5 (cladribine 10 MG Oral Tablet) } PackGPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122654{6 (cladribine 10 MG Oral Tablet) } PackGPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122649{7 (cladribine 10 MG Oral Tablet) } PackGPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122647{8 (cladribine 10 MG Oral Tablet) } PackGPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122635{9 (cladribine 10 MG Oral Tablet) } PackGPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122660cladribine 10 MG (10) Oral Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122658cladribine 10 MG (4) Oral Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122656cladribine 10 MG (5) Oral Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122654cladribine 10 MG (6) Oral Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122649cladribine 10 MG (7) Oral Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122647cladribine 10 MG (8) Oral Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122635Cladribine 10 MG (9) Oral Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122634cladribine 10 MG Oral TabletPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122641Mavenclad 10 MG Oral TabletPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122661MAVENCLAD 10 Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122659MAVENCLAD 4 Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122657MAVENCLAD 5 Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122655MAVENCLAD 6 Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122650MAVENCLAD 7 Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122648MAVENCLAD 8 Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122642MAVENCLAD 9 Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122641cladribine 10 MG Oral Tablet [Mavenclad]SBD9c75e30a-a410-40f1-b653-04d532bd914410
2122634cladribine 10 MG Oral TabletSCD9c75e30a-a410-40f1-b653-04d532bd914410
2122641Mavenclad 10 MG Oral TabletSY9c75e30a-a410-40f1-b653-04d532bd914410
2122661Mavenclad 10 Tablet PackSY9c75e30a-a410-40f1-b653-04d532bd914410
2122659Mavenclad 4 Tablet PackSY9c75e30a-a410-40f1-b653-04d532bd914410
2122657Mavenclad 5 Tablet PackSY9c75e30a-a410-40f1-b653-04d532bd914410
2122655Mavenclad 6 Tablet PackSY9c75e30a-a410-40f1-b653-04d532bd914410
2122650Mavenclad 7 Tablet PackSY9c75e30a-a410-40f1-b653-04d532bd914410
2122648Mavenclad 8 Tablet PackSY9c75e30a-a410-40f1-b653-04d532bd914410
2122642Mavenclad 9 Tablet PackSY9c75e30a-a410-40f1-b653-04d532bd914410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44087-4000-0440874000005 BLISTER PACK in 1 CARTON (44087-4000-0) / 2 TABLET in 1 BLISTER PACK5 blister pack2019-04-010000-00-00NoNoCurrent
44087-4000-4440874000044 BLISTER PACK in 1 CARTON (44087-4000-4) / 1 TABLET in 1 BLISTER PACK4 blister pack2019-04-010000-00-00NoNoCurrent
44087-4000-5440874000055 BLISTER PACK in 1 CARTON (44087-4000-5) / 1 TABLET in 1 BLISTER PACK5 blister pack2019-04-010000-00-00NoNoCurrent
44087-4000-6440874000066 BLISTER PACK in 1 CARTON (44087-4000-6) / 1 TABLET in 1 BLISTER PACK6 blister pack2019-04-010000-00-00NoNoCurrent
44087-4000-7440874000077 BLISTER PACK in 1 CARTON (44087-4000-7) / 1 TABLET in 1 BLISTER PACK7 blister pack2019-04-010000-00-00NoNoCurrent
44087-4000-8440874000088 BLISTER PACK in 1 CARTON (44087-4000-8) / 1 TABLET in 1 BLISTER PACK8 blister pack2019-04-010000-00-00NoNoCurrent
44087-4000-9440874000099 BLISTER PACK in 1 CARTON (44087-4000-9) / 1 TABLET in 1 BLISTER PACK9 blister pack2019-04-010000-00-00NoNoCurrent