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 ID | 0703-4004_125b3dd3-f589-45b0-8737-c88b1be4082c |
| NDC | 0703-4004 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Romidepsin |
| Generic Name | Romidepsin |
| Dosage Form | Injection, Solution, Concentrate |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2020-04-14 |
| Marketing Category | NDA / NDA |
| Application Number | NDA208574 |
| Labeler Name | Teva Parenteral Medicines, Inc. |
| Substance Name | ROMIDEPSIN |
| Active Ingredient Strength | 5 mg/mL |
| Pharm Classes | Bile Salt Export Pump Inhibitors [MoA], Histone Deacetylase Inhibitor [EPC], Histone Deacetylase Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2020-04-14 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA208574 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2020-04-14 |
| Ingredient | Strength |
|---|---|
| ROMIDEPSIN | 5 mg/mL |
| SPL SET ID: | a0478684-e477-4b52-97a9-04a76e794c87 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0069-0983 | Romidepsin | romidepsin |
| 0703-3071 | Romidepsin | Romidepsin |
| 0703-3125 | Romidepsin | romidepsin |
| 0703-4004 | Romidepsin | Romidepsin |
| 63323-926 | Romidepsin | Romidepsin |
| 59572-984 | ISTODAX | romidepsin |