istodax

Generic: romidepsin

Labeler: celgene corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name istodax
Generic Name romidepsin
Labeler celgene corporation
Dosage Form KIT
Manufacturer
Celgene Corporation

Identifiers & Regulatory

Product NDC 59572-984
Product ID 59572-984_08c46856-2700-4885-ba5d-dced9d8056e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022393
Listing Expiration 2026-12-31
Marketing Start 2010-01-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59572984
Hyphenated Format 59572-984

Supplemental Identifiers

RxCUI
877513 877516

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 istodax (source: ndc)
Generic Name romidepsin (source: ndc)
Application Number NDA022393 (source: ndc)

Resolved Composition

Strengths
  • 10 mg
  • 11 mg
  • 22 mg
  • 2.4 ml
  • 2.2 ml
  • 80 %
  • 20 %
source: label
Packaging
  • 1 KIT in 1 CARTON (59572-984-01) * 2.2 mL in 1 VIAL, GLASS (59572-962-10) * 2.4 mL in 1 VIAL, GLASS (59572-973-02)
source: ndc

Packages (1)

59572-984-01 1 KIT in 1 CARTON (59572-984-01) * 2.2 mL in 1 VIAL, GLASS (59572-962-10) * 2.4 mL in 1 VIAL, GLASS (59572-973-02)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

ISTODAX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "08c46856-2700-4885-ba5d-dced9d8056e1", "openfda": {"rxcui": ["877513", "877516"], "spl_set_id": ["03b39d40-90fe-11df-9de6-0002a5d5c51b"], "manufacturer_name": ["Celgene Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (59572-984-01)  *  2.2 mL in 1 VIAL, GLASS (59572-962-10)  *  2.4 mL in 1 VIAL, GLASS (59572-973-02)", "package_ndc": "59572-984-01", "marketing_start_date": "20100104"}], "brand_name": "ISTODAX", "product_id": "59572-984_08c46856-2700-4885-ba5d-dced9d8056e1", "dosage_form": "KIT", "product_ndc": "59572-984", "generic_name": "romidepsin", "labeler_name": "Celgene Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISTODAX", "application_number": "NDA022393", "marketing_category": "NDA", "marketing_start_date": "20100104", "listing_expiration_date": "20261231"}