FDA.reportPublic FDA data

Cladribine

Product NDC
62049-286
11-digit product format
620490286
Labeler code
62049
Product ID
62049-286_8a24939c-6118-83ad-5a85-5277500bb20a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cladribine
Dosage form
TABLET
Route
ORAL
Labeler
Genvion Corporation
Application
ANDA218425
Marketing category
ANDA
Marketing start
2025-11-25
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
Cladribine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLADRIBINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii47M74X9YT5
Rxcui2122634, 2122635, 2122647, 2122649, 2122654, 2122656, 2122658, 2122660

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62049-286-04Cladribine4 in 1 CARTONTABLET42
62049-286-05Cladribine5 in 1 CARTONTABLET52
62049-286-06Cladribine6 in 1 CARTONTABLET62
62049-286-07Cladribine7 in 1 CARTONTABLET72
62049-286-08Cladribine8 in 1 CARTONTABLET82
62049-286-09Cladribine9 in 1 CARTONTABLET92
62049-286-10Cladribine10 in 1 CARTONTABLET102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2122660{10 (cladribine 10 MG Oral Tablet) } PackGPCKf1d650a5-4205-720b-f39b-4213277b66122
2122658{4 (cladribine 10 MG Oral Tablet) } PackGPCKf1d650a5-4205-720b-f39b-4213277b66122
2122656{5 (cladribine 10 MG Oral Tablet) } PackGPCKf1d650a5-4205-720b-f39b-4213277b66122
2122654{6 (cladribine 10 MG Oral Tablet) } PackGPCKf1d650a5-4205-720b-f39b-4213277b66122
2122649{7 (cladribine 10 MG Oral Tablet) } PackGPCKf1d650a5-4205-720b-f39b-4213277b66122
2122647{8 (cladribine 10 MG Oral Tablet) } PackGPCKf1d650a5-4205-720b-f39b-4213277b66122
2122635{9 (cladribine 10 MG Oral Tablet) } PackGPCKf1d650a5-4205-720b-f39b-4213277b66122
2122660cladribine 10 MG (10) Oral Tablet PackPSNf1d650a5-4205-720b-f39b-4213277b66122
2122658cladribine 10 MG (4) Oral Tablet PackPSNf1d650a5-4205-720b-f39b-4213277b66122
2122656cladribine 10 MG (5) Oral Tablet PackPSNf1d650a5-4205-720b-f39b-4213277b66122
2122654cladribine 10 MG (6) Oral Tablet PackPSNf1d650a5-4205-720b-f39b-4213277b66122
2122649cladribine 10 MG (7) Oral Tablet PackPSNf1d650a5-4205-720b-f39b-4213277b66122
2122647cladribine 10 MG (8) Oral Tablet PackPSNf1d650a5-4205-720b-f39b-4213277b66122
2122635Cladribine 10 MG (9) Oral Tablet PackPSNf1d650a5-4205-720b-f39b-4213277b66122
2122634cladribine 10 MG Oral TabletPSNf1d650a5-4205-720b-f39b-4213277b66122
2122634cladribine 10 MG Oral TabletSCDf1d650a5-4205-720b-f39b-4213277b66122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62049-286-04620490286044 TABLET in 1 CARTON (62049-286-04) 4 tablet2025-11-25NoNoCurrent
62049-286-05620490286055 TABLET in 1 CARTON (62049-286-05) 5 tablet2025-11-25NoNoCurrent
62049-286-06620490286066 TABLET in 1 CARTON (62049-286-06) 6 tablet2025-11-25NoNoCurrent
62049-286-07620490286077 TABLET in 1 CARTON (62049-286-07) 7 tablet2025-11-25NoNoCurrent
62049-286-08620490286088 TABLET in 1 CARTON (62049-286-08) 8 tablet2025-11-25NoNoCurrent
62049-286-09620490286099 TABLET in 1 CARTON (62049-286-09) 9 tablet2025-11-25NoNoCurrent
62049-286-106204902861010 TABLET in 1 CARTON (62049-286-10) 10 tablet2025-11-25NoNoCurrent