Romidepsin
- Product NDC
- 0703-4004
- 11-digit product format
- 007034004
- Labeler code
- 0703
- Product ID
- 0703-4004_125b3dd3-f589-45b0-8737-c88b1be4082c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Romidepsin
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Teva Parenteral Medicines, Inc.
- Application
- NDA208574
- Marketing category
- NDA
- Marketing start
- 2020-04-14
- Marketing end
- 0000-00-00
- Substance
- ROMIDEPSIN
- Active strength
- 5 mg/mL
- Pharmacologic 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
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0703-4004-01 | 00703400401 | 1 VIAL in 1 CARTON (0703-4004-01) > 5.5 mL in 1 VIAL | 1 vial | 2020-04-14 | 0000-00-00 | No | No | Current |