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NDC 00703-4004-01 Romidepsin 5 mg/mL Details
Romidepsin 5 mg/mL
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.
MedlinePlus Drug Summary
Romidepsin injection is used to treat cutaneous T-cell lymphoma (CTCL; a group of cancers of the immune system that first appear as skin rashes) in people who have already been treated with at least one other medication. Romidepsin injection is also used to treat peripheral T-cell lymphoma (PTCL; a type of non-Hodgkin's lymphoma) in people who have already been treated with at least one other medication. Romidepsin injection is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by slowing the growth of cancer cells.
Related Packages: 00703-4004-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Romidepsin Injection
Product Information
| NDC | 00703-4004 |
|---|---|
| Product ID | 0703-4004_bc6afb1c-b9c9-4ea2-baac-433a24b0300d |
| Associated GPIs | 21531560002030 |
| GCN Sequence Number | 080845 |
| GCN Sequence Number Description | romidepsin VIAL 27.5/5.5ML INTRAVEN |
| HIC3 | V3A |
| HIC3 Description | ANTINEOPLAST,HISTONE DEACETYLASE (HDAC) INHIBITORS |
| GCN | 47827 |
| HICL Sequence Number | 036898 |
| HICL Sequence Number Description | ROMIDEPSIN |
| Brand/Generic | Generic |
| Proprietary Name | Romidepsin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Romidepsin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/mL |
| Substance Name | ROMIDEPSIN |
| Labeler Name | Teva Parenteral Medicines, Inc. |
| Pharmaceutical Class | 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 Polype |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208574 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00703-4004-01 (00703400401)
| NDC Package Code | 0703-4004-01 |
|---|---|
| Billing NDC | 00703400401 |
| Package | 1 VIAL in 1 CARTON (0703-4004-01) / 5.5 mL in 1 VIAL |
| Marketing Start Date | 2020-04-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |