Ellence
- Product NDC
- 0009-5093
- 11-digit product format
- 000095093
- Labeler code
- 0009
- Product ID
- 0009-5093_ec48409f-8260-42aa-89bc-222c2db99ea3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- epirubicin hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Pharmacia & Upjohn Company LLC
- Application
- NDA050778
- Marketing category
- NDA
- Marketing start
- 1999-09-15
- Substance
- EPIRUBICIN HYDROCHLORIDE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ellence
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EPIRUBICIN HYDROCHLORIDE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 22966TX7J5 |
| Rxcui | 1732182, 1732183, 1732186, 1732187 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0009-5093-01 | Ellence | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 25 |
| 0009-5093-01 | Ellence | 100 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 100 | | 25 |
| 0009-5093-10 | Ellence | 100 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 100 | | 25 |
| 0009-5093-10 | Ellence | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 25 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0009-5093 | ELLENCE (EPIRUBICIN HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC] | 22 | Current NDC, Legacy NDC, 4 package rows | 20250326_0a03c798-a652-4895-b29c-3b521a89ba42.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0009-5093-01 | 00009509301 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5093-01) > 100 mL in 1 VIAL, SINGLE-DOSE | 1999-09-15 | 0000-00-00 | No | No | Current |
| 0009-5093-10 | 00009509310 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5093-10) / 100 mL in 1 VIAL, SINGLE-DOSE | 2025-03-24 | | No | No | Current |