cladribine

Generic: cladribine

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cladribine
Generic Name cladribine
Labeler apotex corp.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cladribine 10 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-4791
Product ID 60505-4791_f29f726e-f858-7aff-d874-b322d5ca860c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218425
Listing Expiration 2026-12-31
Marketing Start 2025-11-25

Pharmacologic Class

Established (EPC)
purine antimetabolite [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605054791
Hyphenated Format 60505-4791

Supplemental Identifiers

RxCUI
2122634
UNII
47M74X9YT5
NUI
N0000175712

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cladribine (source: ndc)
Generic Name cladribine (source: ndc)
Application Number ANDA218425 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 CARTON (60505-4791-1)
  • 4 TABLET in 1 CARTON (60505-4791-4)
  • 5 TABLET in 1 CARTON (60505-4791-5)
  • 6 TABLET in 1 CARTON (60505-4791-6)
  • 7 TABLET in 1 CARTON (60505-4791-7)
  • 8 TABLET in 1 CARTON (60505-4791-8)
  • 9 TABLET in 1 CARTON (60505-4791-9)
source: ndc

Packages (7)

60505-4791-1 10 TABLET in 1 CARTON (60505-4791-1) 60505-4791-4 4 TABLET in 1 CARTON (60505-4791-4) 60505-4791-5 5 TABLET in 1 CARTON (60505-4791-5) 60505-4791-6 6 TABLET in 1 CARTON (60505-4791-6) 60505-4791-7 7 TABLET in 1 CARTON (60505-4791-7) 60505-4791-8 8 TABLET in 1 CARTON (60505-4791-8) 60505-4791-9 9 TABLET in 1 CARTON (60505-4791-9)

Ingredients (1)

cladribine (10 mg/1)

Linked Drug Pages (1)

Cladribine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f29f726e-f858-7aff-d874-b322d5ca860c", "openfda": {"nui": ["N0000175712"], "unii": ["47M74X9YT5"], "rxcui": ["2122634"], "spl_set_id": ["407c52d5-6498-7da5-da35-acc9ca73ced3"], "pharm_class_epc": ["Purine Antimetabolite [EPC]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 CARTON (60505-4791-1)", "package_ndc": "60505-4791-1", "marketing_start_date": "20251125"}, {"sample": false, "description": "4 TABLET in 1 CARTON (60505-4791-4)", "package_ndc": "60505-4791-4", "marketing_start_date": "20251125"}, {"sample": false, "description": "5 TABLET in 1 CARTON (60505-4791-5)", "package_ndc": "60505-4791-5", "marketing_start_date": "20251125"}, {"sample": false, "description": "6 TABLET in 1 CARTON (60505-4791-6)", "package_ndc": "60505-4791-6", "marketing_start_date": "20251125"}, {"sample": false, "description": "7 TABLET in 1 CARTON (60505-4791-7)", "package_ndc": "60505-4791-7", "marketing_start_date": "20251125"}, {"sample": false, "description": "8 TABLET in 1 CARTON (60505-4791-8)", "package_ndc": "60505-4791-8", "marketing_start_date": "20251125"}, {"sample": false, "description": "9 TABLET in 1 CARTON (60505-4791-9)", "package_ndc": "60505-4791-9", "marketing_start_date": "20251125"}], "brand_name": "Cladribine", "product_id": "60505-4791_f29f726e-f858-7aff-d874-b322d5ca860c", "dosage_form": "TABLET", "pharm_class": ["Purine Antimetabolite [EPC]"], "product_ndc": "60505-4791", "generic_name": "Cladribine", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cladribine", "active_ingredients": [{"name": "CLADRIBINE", "strength": "10 mg/1"}], "application_number": "ANDA218425", "marketing_category": "ANDA", "marketing_start_date": "20251125", "listing_expiration_date": "20261231"}