FDA.reportPublic FDA data

Cladribine

Product NDC
60505-4791
11-digit product format
605054791
Labeler code
60505
Product ID
60505-4791_f29f726e-f858-7aff-d874-b322d5ca860c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cladribine
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLADRIBINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii47M74X9YT5

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
60505-4791-1Cladribine10 in 1 CARTONTABLET103
60505-4791-4Cladribine4 in 1 CARTONTABLET43
60505-4791-5Cladribine5 in 1 CARTONTABLET53
60505-4791-6Cladribine6 in 1 CARTONTABLET63
60505-4791-7Cladribine7 in 1 CARTONTABLET73
60505-4791-8Cladribine8 in 1 CARTONTABLET83
60505-4791-9Cladribine9 in 1 CARTONTABLET93

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4791-1EA - Each60505-4791212d5c31-e7cf-4f67-a394-219da336a47712025-12-16
60505-4791-4EA - Each60505-47916423fc1f-af6a-4ccc-b16b-c15bbb29cd9e12025-12-16
60505-4791-5EA - Each60505-479192dfb3c9-4621-4d4d-8de9-dd4618e8321e12025-12-16
60505-4791-6EA - Each60505-47913614f6fc-4468-4975-b3c3-5f8e35dd7d9012025-12-16
60505-4791-7EA - Each60505-4791ccbe0e40-8cf0-4854-ac4c-6bf5b7aab56a12025-12-16
60505-4791-8EA - Each60505-4791b5590580-ccb2-4af3-bcb6-7feb2bd99a2512025-12-16
60505-4791-9EA - Each60505-4791efd793c4-1836-4d79-aa1a-9e5e370d4f2b12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2122660{10 (cladribine 10 MG Oral Tablet) } PackGPCK407c52d5-6498-7da5-da35-acc9ca73ced33
2122658{4 (cladribine 10 MG Oral Tablet) } PackGPCK407c52d5-6498-7da5-da35-acc9ca73ced33
2122656{5 (cladribine 10 MG Oral Tablet) } PackGPCK407c52d5-6498-7da5-da35-acc9ca73ced33
2122654{6 (cladribine 10 MG Oral Tablet) } PackGPCK407c52d5-6498-7da5-da35-acc9ca73ced33
2122649{7 (cladribine 10 MG Oral Tablet) } PackGPCK407c52d5-6498-7da5-da35-acc9ca73ced33
2122647{8 (cladribine 10 MG Oral Tablet) } PackGPCK407c52d5-6498-7da5-da35-acc9ca73ced33
2122635{9 (cladribine 10 MG Oral Tablet) } PackGPCK407c52d5-6498-7da5-da35-acc9ca73ced33
2122660cladribine 10 MG (10) Oral Tablet PackPSN407c52d5-6498-7da5-da35-acc9ca73ced33
2122658cladribine 10 MG (4) Oral Tablet PackPSN407c52d5-6498-7da5-da35-acc9ca73ced33
2122656cladribine 10 MG (5) Oral Tablet PackPSN407c52d5-6498-7da5-da35-acc9ca73ced33
2122654cladribine 10 MG (6) Oral Tablet PackPSN407c52d5-6498-7da5-da35-acc9ca73ced33
2122649cladribine 10 MG (7) Oral Tablet PackPSN407c52d5-6498-7da5-da35-acc9ca73ced33
2122647cladribine 10 MG (8) Oral Tablet PackPSN407c52d5-6498-7da5-da35-acc9ca73ced33
2122635Cladribine 10 MG (9) Oral Tablet PackPSN407c52d5-6498-7da5-da35-acc9ca73ced33
2122634cladribine 10 MG Oral TabletPSN407c52d5-6498-7da5-da35-acc9ca73ced33
2122634cladribine 10 MG Oral TabletSCD407c52d5-6498-7da5-da35-acc9ca73ced33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60505-4791-16050547910110 TABLET in 1 CARTON (60505-4791-1) 10 tablet2025-11-25NoNoCurrent
60505-4791-4605054791044 TABLET in 1 CARTON (60505-4791-4) 4 tablet2025-11-25NoNoCurrent
60505-4791-5605054791055 TABLET in 1 CARTON (60505-4791-5) 5 tablet2025-11-25NoNoCurrent
60505-4791-6605054791066 TABLET in 1 CARTON (60505-4791-6) 6 tablet2025-11-25NoNoCurrent
60505-4791-7605054791077 TABLET in 1 CARTON (60505-4791-7) 7 tablet2025-11-25NoNoCurrent
60505-4791-8605054791088 TABLET in 1 CARTON (60505-4791-8) 8 tablet2025-11-25NoNoCurrent
60505-4791-9605054791099 TABLET in 1 CARTON (60505-4791-9) 9 tablet2025-11-25NoNoCurrent