FDA.reportPublic FDA data

Cladribine

Product NDC
0781-8201
11-digit product format
007818201
Labeler code
0781
Product ID
0781-8201_4ff7cb90-f8cc-5804-e063-6394a90ac0a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cladribine
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc.
Application
ANDA215547
Marketing category
ANDA
Marketing start
2026-04-23
Substance
CLADRIBINE
Active strength
10 mg/1
Pharmacologic classes
Purine Antimetabolite [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
0781-8201-37Cladribine9 in 1 CARTONTABLET91
0781-8201-51Cladribine5 in 1 CARTONTABLET51
0781-8201-68Cladribine6 in 1 CARTONTABLET61
0781-8201-71Cladribine7 in 1 CARTONTABLET71
0781-8201-80Cladribine10 in 1 CARTONTABLET101
0781-8201-85Cladribine8 in 1 CARTONTABLET81
0781-8201-94Cladribine4 in 1 CARTONTABLET41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-8201-37EA - Each0781-820108994810-3993-4a67-980c-27ae49df2e0612026-05-22
0781-8201-51EA - Each0781-820129955eca-5eda-4c51-9af2-ff15ee6e688812026-05-22
0781-8201-68EA - Each0781-8201c101861a-0bc4-4a6d-945c-140b02b6938d12026-05-22
0781-8201-71EA - Each0781-8201afce2a10-5b71-4031-a883-5cfc50b451e012026-05-22
0781-8201-80EA - Each0781-8201e0d0a697-6358-43ce-8371-4958907c52a412026-05-22
0781-8201-85EA - Each0781-82018bc384a9-610e-4376-ba1b-cd9bd3cc7c6312026-05-22
0781-8201-94EA - Each0781-8201d186198b-b9e4-4eb2-9a83-603ca73b057d12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2122660{10 (cladribine 10 MG Oral Tablet) } PackGPCKe0b363cb-db83-44d6-89d0-1f7176be74591
2122658{4 (cladribine 10 MG Oral Tablet) } PackGPCKe0b363cb-db83-44d6-89d0-1f7176be74591
2122656{5 (cladribine 10 MG Oral Tablet) } PackGPCKe0b363cb-db83-44d6-89d0-1f7176be74591
2122654{6 (cladribine 10 MG Oral Tablet) } PackGPCKe0b363cb-db83-44d6-89d0-1f7176be74591
2122649{7 (cladribine 10 MG Oral Tablet) } PackGPCKe0b363cb-db83-44d6-89d0-1f7176be74591
2122647{8 (cladribine 10 MG Oral Tablet) } PackGPCKe0b363cb-db83-44d6-89d0-1f7176be74591
2122635{9 (cladribine 10 MG Oral Tablet) } PackGPCKe0b363cb-db83-44d6-89d0-1f7176be74591
2122660cladribine 10 MG (10) Oral Tablet PackPSNe0b363cb-db83-44d6-89d0-1f7176be74591
2122658cladribine 10 MG (4) Oral Tablet PackPSNe0b363cb-db83-44d6-89d0-1f7176be74591
2122656cladribine 10 MG (5) Oral Tablet PackPSNe0b363cb-db83-44d6-89d0-1f7176be74591
2122654cladribine 10 MG (6) Oral Tablet PackPSNe0b363cb-db83-44d6-89d0-1f7176be74591
2122649cladribine 10 MG (7) Oral Tablet PackPSNe0b363cb-db83-44d6-89d0-1f7176be74591
2122647cladribine 10 MG (8) Oral Tablet PackPSNe0b363cb-db83-44d6-89d0-1f7176be74591
2122635Cladribine 10 MG (9) Oral Tablet PackPSNe0b363cb-db83-44d6-89d0-1f7176be74591
2122634cladribine 10 MG Oral TabletPSNe0b363cb-db83-44d6-89d0-1f7176be74591
2122634cladribine 10 MG Oral TabletSCDe0b363cb-db83-44d6-89d0-1f7176be74591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0781-8201-37007818201379 TABLET in 1 CARTON (0781-8201-37) 9 tablet2026-04-23NoNoHistorical
0781-8201-51007818201515 TABLET in 1 CARTON (0781-8201-51) 5 tablet2026-04-23NoNoHistorical
0781-8201-68007818201686 TABLET in 1 CARTON (0781-8201-68) 6 tablet2026-04-23NoNoHistorical
0781-8201-71007818201717 TABLET in 1 CARTON (0781-8201-71) 7 tablet2026-04-23NoNoHistorical
0781-8201-800078182018010 TABLET in 1 CARTON (0781-8201-80) 10 tablet2026-04-23NoNoHistorical
0781-8201-85007818201858 TABLET in 1 CARTON (0781-8201-85) 8 tablet2026-04-23NoNoHistorical
0781-8201-94007818201944 TABLET in 1 CARTON (0781-8201-94) 4 tablet2026-04-23NoNoHistorical