NDC 0703-3071

Romidepsin

Romidepsin

Romidepsin is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Teva Parenteral Medicines, Inc.. The primary component is Romidepsin.

Product ID0703-3071_1c266507-2ce7-4531-9f05-b3e7820b0fea
NDC0703-3071
Product TypeHuman Prescription Drug
Proprietary NameRomidepsin
Generic NameRomidepsin
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-04-14
Marketing CategoryNDA / NDA
Application NumberNDA208574
Labeler NameTeva Parenteral Medicines, Inc.
Substance NameROMIDEPSIN
Active Ingredient Strength5 mg/mL
Pharm ClassesHistone Deacetylase Inhibitor [EPC],Histone Deacetylase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0703-3071-01

1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3071-01) > 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2020-04-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0703-3071-01 [00703307101]

Romidepsin INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryNDA
Application NumberNDA208574
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-14
Marketing End Date2020-04-14

Drug Details

Active Ingredients

IngredientStrength
ROMIDEPSIN5 mg/mL

OpenFDA Data

SPL SET ID:a0478684-e477-4b52-97a9-04a76e794c87
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2289413
  • 2289411
    • UPC Code
  • 0307033071015
  • 0307034004012

    • Pharmacological Class

    • Histone Deacetylase Inhibitor [EPC]
    • Histone Deacetylase Inhibitors [MoA]

    NDC Crossover Matching brand name "Romidepsin" or generic name "Romidepsin"

    NDCBrand NameGeneric Name
    0069-0983Romidepsinromidepsin
    0703-3071RomidepsinRomidepsin
    0703-3125Romidepsinromidepsin
    0703-4004RomidepsinRomidepsin
    63323-926RomidepsinRomidepsin
    59572-984ISTODAXromidepsin
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