ISTODAX
- Product NDC
- 59572-984
- 11-digit product format
- 595720984
- Labeler code
- 59572
- Product ID
- 59572-984_08c46856-2700-4885-ba5d-dced9d8056e1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- romidepsin
- Dosage form
- KIT
- Labeler
- Celgene Corporation
- Application
- NDA022393
- Marketing category
- NDA
- Marketing start
- 2010-01-04
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ISTODAX
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 877513, 877516 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59572-962-10 | ISTODAX | 2.2 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 2.2 mL | 10 mg in 2mL | 21 |
| 59572-984-01 | ISTODAX | 1 in 1 CARTON | KIT | 1 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59572-984 | ISTODAX (ROMIDEPSIN) KIT [CELGENE CORPORATION] | 21 | Current NDC, Legacy NDC, 2 package rows | 20230603_03b39d40-90fe-11df-9de6-0002a5d5c51b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59572-962-10 | 59572096210 | 2.2 mL in 1 VIAL, GLASS | 2.2 ml | | | | | Historical |
| 59572-984-01 | 59572098401 | 1 KIT in 1 CARTON (59572-984-01) * 2.2 mL in 1 VIAL, GLASS (59572-962-10) * 2.4 mL in 1 VIAL, GLASS (59572-973-02) | 1 kit | 2010-01-04 | 0000-00-00 | No | No | Current |