cladribine

Generic: cladribine

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

Drug Facts

Product Profile

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

cladribine 1 mg/mL

Manufacturer
Hisun Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 42658-010
Product ID 42658-010_2c5c0edf-8718-40f2-e063-6294a90aacd0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210856
Listing Expiration 2026-12-31
Marketing Start 2020-05-18

Pharmacologic Class

Established (EPC)
purine antimetabolite [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42658010
Hyphenated Format 42658-010

Supplemental Identifiers

RxCUI
240754
UPC
0342658010919
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 ANDA210856 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 mL in 1 VIAL, SINGLE-DOSE (42658-010-91)
source: ndc

Packages (1)

42658-010-91 1 mL in 1 VIAL, SINGLE-DOSE (42658-010-91)

Ingredients (1)

cladribine (1 mg/mL)

Linked Drug Pages (2)

Cladribine ndc-match (0.9) Cladribine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2c5c0edf-8718-40f2-e063-6294a90aacd0", "openfda": {"nui": ["N0000175712"], "upc": ["0342658010919"], "unii": ["47M74X9YT5"], "rxcui": ["240754"], "spl_set_id": ["f538cba9-001a-4a21-e053-2a95a90a00ec"], "pharm_class_epc": ["Purine Antimetabolite [EPC]"], "manufacturer_name": ["Hisun Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL, SINGLE-DOSE (42658-010-91)", "package_ndc": "42658-010-91", "marketing_start_date": "20230228"}], "brand_name": "Cladribine", "product_id": "42658-010_2c5c0edf-8718-40f2-e063-6294a90aacd0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Purine Antimetabolite [EPC]"], "product_ndc": "42658-010", "generic_name": "Cladribine", "labeler_name": "Hisun Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cladribine", "active_ingredients": [{"name": "CLADRIBINE", "strength": "1 mg/mL"}], "application_number": "ANDA210856", "marketing_category": "ANDA", "marketing_start_date": "20200518", "listing_expiration_date": "20261231"}