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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218425-001CLADRIBINECLADRIBINE10MGTABLET / ORALAB2025-11-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A218425-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A218425-001CLADRIBINE10MGTABLET / ORALAB2025-11-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218425-001CLADRIBINE10MGTABLET / ORALAB2025-11-2431067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218425-001CLADRIBINE10MGTABLET / ORALAB2025-11-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218425-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218425-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218425-001AB1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
47M74X9YT5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2122634Internal RxNorm lookup
2122635Internal RxNorm lookup
2122647Internal RxNorm lookup
2122649Internal RxNorm lookup
2122654Internal RxNorm lookup
2122656Internal RxNorm lookup
2122658Internal RxNorm lookup
2122660Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
407c52d5-6498-7da5-da35-acc9ca73ced3Available on FDA.report

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

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CladribineCLADRIBINEApotex Corp.407c52d5-6498-7da5-da35-acc9ca73ced32026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218425
application number: ANDA218425
ndc (product): 60505-4791
CladribineCLADRIBINEGenvion Corporationf1d650a5-4205-720b-f39b-4213277b66122025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218425
application number: ANDA218425

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