romidepsin

Generic: romidepsin

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name romidepsin
Generic Name romidepsin
Labeler fresenius kabi usa, llc
Dosage Form KIT
Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-926
Product ID 63323-926_89d989ef-6d9f-4b93-a271-5a9664b0f328
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206254
Listing Expiration 2026-12-31
Marketing Start 2021-10-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323926
Hyphenated Format 63323-926

Supplemental Identifiers

RxCUI
877513
UPC
0363323925178

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 romidepsin (source: ndc)
Generic Name romidepsin (source: ndc)
Application Number ANDA206254 (source: ndc)

Resolved Composition

Strengths
  • 10 mg
  • 11 mg
  • 22 mg
  • 2.2 ml
  • 80 %
  • 20 %
source: label
Packaging
  • 1 KIT in 1 CARTON (63323-926-88) * 2 mL in 1 VIAL, SINGLE-DOSE (63323-925-17) * 2.2 mL in 1 VIAL, SINGLE-DOSE (63323-922-03)
source: ndc

Packages (1)

63323-926-88 1 KIT in 1 CARTON (63323-926-88) * 2 mL in 1 VIAL, SINGLE-DOSE (63323-925-17) * 2.2 mL in 1 VIAL, SINGLE-DOSE (63323-922-03)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Romidepsin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "89d989ef-6d9f-4b93-a271-5a9664b0f328", "openfda": {"upc": ["0363323925178"], "rxcui": ["877513"], "spl_set_id": ["73a2028d-6735-4cd4-b63d-d072df9927a1"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (63323-926-88)  *  2 mL in 1 VIAL, SINGLE-DOSE (63323-925-17)  *  2.2 mL in 1 VIAL, SINGLE-DOSE (63323-922-03)", "package_ndc": "63323-926-88", "marketing_start_date": "20211012"}], "brand_name": "Romidepsin", "product_id": "63323-926_89d989ef-6d9f-4b93-a271-5a9664b0f328", "dosage_form": "KIT", "product_ndc": "63323-926", "generic_name": "Romidepsin", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Romidepsin", "application_number": "ANDA206254", "marketing_category": "ANDA", "marketing_start_date": "20211012", "listing_expiration_date": "20261231"}