mavenclad

Generic: cladribine

Labeler: emd serono, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mavenclad
Generic Name cladribine
Labeler emd serono, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cladribine 10 mg/1

Manufacturer
EMD Serono, Inc.

Identifiers & Regulatory

Product NDC 44087-4000
Product ID 44087-4000_4f6e2bce-df90-4b30-a969-59810b302b52
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022561
Listing Expiration 2026-12-31
Marketing Start 2019-04-01

Pharmacologic Class

Established (EPC)
purine antimetabolite [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 440874000
Hyphenated Format 44087-4000

Supplemental Identifiers

RxCUI
2122634 2122635 2122641 2122642 2122647 2122648 2122649 2122650 2122654 2122655 2122656 2122657 2122658 2122659 2122660 2122661
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 mavenclad (source: ndc)
Generic Name cladribine (source: ndc)
Application Number NDA022561 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (44087-4000-0) / 2 TABLET in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (44087-4000-4) / 1 TABLET in 1 BLISTER PACK
  • 5 BLISTER PACK in 1 CARTON (44087-4000-5) / 1 TABLET in 1 BLISTER PACK
  • 6 BLISTER PACK in 1 CARTON (44087-4000-6) / 1 TABLET in 1 BLISTER PACK
  • 7 BLISTER PACK in 1 CARTON (44087-4000-7) / 1 TABLET in 1 BLISTER PACK
  • 8 BLISTER PACK in 1 CARTON (44087-4000-8) / 1 TABLET in 1 BLISTER PACK
  • 9 BLISTER PACK in 1 CARTON (44087-4000-9) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (7)

44087-4000-0 5 BLISTER PACK in 1 CARTON (44087-4000-0) / 2 TABLET in 1 BLISTER PACK 44087-4000-4 4 BLISTER PACK in 1 CARTON (44087-4000-4) / 1 TABLET in 1 BLISTER PACK 44087-4000-5 5 BLISTER PACK in 1 CARTON (44087-4000-5) / 1 TABLET in 1 BLISTER PACK 44087-4000-6 6 BLISTER PACK in 1 CARTON (44087-4000-6) / 1 TABLET in 1 BLISTER PACK 44087-4000-7 7 BLISTER PACK in 1 CARTON (44087-4000-7) / 1 TABLET in 1 BLISTER PACK 44087-4000-8 8 BLISTER PACK in 1 CARTON (44087-4000-8) / 1 TABLET in 1 BLISTER PACK 44087-4000-9 9 BLISTER PACK in 1 CARTON (44087-4000-9) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

cladribine (10 mg/1)

Linked Drug Pages (1)

Mavenclad ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4f6e2bce-df90-4b30-a969-59810b302b52", "openfda": {"nui": ["N0000175712"], "unii": ["47M74X9YT5"], "rxcui": ["2122634", "2122635", "2122641", "2122642", "2122647", "2122648", "2122649", "2122650", "2122654", "2122655", "2122656", "2122657", "2122658", "2122659", "2122660", "2122661"], "spl_set_id": ["9c75e30a-a410-40f1-b653-04d532bd9144"], "pharm_class_epc": ["Purine Antimetabolite [EPC]"], "manufacturer_name": ["EMD Serono, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (44087-4000-0)  / 2 TABLET in 1 BLISTER PACK", "package_ndc": "44087-4000-0", "marketing_start_date": "20190401"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (44087-4000-4)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "44087-4000-4", "marketing_start_date": "20190401"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (44087-4000-5)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "44087-4000-5", "marketing_start_date": "20190401"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (44087-4000-6)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "44087-4000-6", "marketing_start_date": "20190401"}, {"sample": false, "description": "7 BLISTER PACK in 1 CARTON (44087-4000-7)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "44087-4000-7", "marketing_start_date": "20190401"}, {"sample": false, "description": "8 BLISTER PACK in 1 CARTON (44087-4000-8)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "44087-4000-8", "marketing_start_date": "20190401"}, {"sample": false, "description": "9 BLISTER PACK in 1 CARTON (44087-4000-9)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "44087-4000-9", "marketing_start_date": "20190401"}], "brand_name": "Mavenclad", "product_id": "44087-4000_4f6e2bce-df90-4b30-a969-59810b302b52", "dosage_form": "TABLET", "pharm_class": ["Purine Antimetabolite [EPC]"], "product_ndc": "44087-4000", "generic_name": "Cladribine", "labeler_name": "EMD Serono, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mavenclad", "active_ingredients": [{"name": "CLADRIBINE", "strength": "10 mg/1"}], "application_number": "NDA022561", "marketing_category": "NDA", "marketing_start_date": "20190401", "listing_expiration_date": "20261231"}