Romidepsin
- Product NDC
- 63323-926
- 11-digit product format
- 633230926
- Labeler code
- 63323
- Product ID
- 63323-926_44fb8ff4-ec3d-4dcf-8e8c-207545d938a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Romidepsin
- Dosage form
- KIT
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA206254
- Marketing category
- ANDA
- Marketing start
- 2021-10-12
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Romidepsin
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 877513 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-925-17 | Romidepsin | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 2 mL | 10 mg in 2mL | 9 |
| 63323-926-88 | Romidepsin | 1 in 1 CARTON | KIT | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-926 | ROMIDEPSIN KIT [FRESENIUS KABI USA, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20211124_73a2028d-6735-4cd4-b63d-d072df9927a1.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 |
|---|
| 63323-925-17 | 63323092517 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | | | | | Historical |
| 63323-926-88 | 63323092688 | 1 KIT in 1 CARTON (63323-926-88) * 2 mL in 1 VIAL, SINGLE-DOSE (63323-925-17) * 2.2 mL in 1 VIAL, SINGLE-DOSE (63323-922-03) | 1 kit | 2021-10-12 | 0000-00-00 | No | No | Current |