cladribine

Generic: cladribine

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cladribine
Generic Name cladribine
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

cladribine 1 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9871
Product ID 0143-9871_5aef0cdc-fa27-47a1-8cce-2a3201aba276
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075405
Listing Expiration 2026-12-31
Marketing Start 2000-02-28

Pharmacologic Class

Established (EPC)
purine antimetabolite [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439871
Hyphenated Format 0143-9871

Supplemental Identifiers

RxCUI
240754
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 ANDA075405 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX, UNIT-DOSE (0143-9871-01) / 10 mL in 1 VIAL
source: ndc

Packages (1)

0143-9871-01 1 VIAL in 1 BOX, UNIT-DOSE (0143-9871-01) / 10 mL in 1 VIAL

Ingredients (1)

cladribine (1 mg/mL)

Linked Drug Pages (1)

Cladribine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5aef0cdc-fa27-47a1-8cce-2a3201aba276", "openfda": {"nui": ["N0000175712"], "unii": ["47M74X9YT5"], "rxcui": ["240754"], "spl_set_id": ["5736aecc-cc1d-47dd-86c0-5fb2e9d70f61"], "pharm_class_epc": ["Purine Antimetabolite [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX, UNIT-DOSE (0143-9871-01)  / 10 mL in 1 VIAL", "package_ndc": "0143-9871-01", "marketing_start_date": "20000228"}], "brand_name": "Cladribine", "product_id": "0143-9871_5aef0cdc-fa27-47a1-8cce-2a3201aba276", "dosage_form": "INJECTION", "pharm_class": ["Purine Antimetabolite [EPC]"], "product_ndc": "0143-9871", "generic_name": "Cladribine", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cladribine", "active_ingredients": [{"name": "CLADRIBINE", "strength": "1 mg/mL"}], "application_number": "ANDA075405", "marketing_category": "ANDA", "marketing_start_date": "20000228", "listing_expiration_date": "20261231"}