Epirubicin Hydrochloride
- Product NDC
- 45963-608
- 11-digit product format
- 459630608
- Labeler code
- 45963
- Product ID
- 45963-608_9688d8b5-3a1b-4802-bdab-6ff651741400
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Epirubicin Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA065445
- Marketing category
- ANDA
- Marketing start
- 2011-11-28
- Marketing end
- 2021-06-30
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45963-608-68 | 45963060868 | 1 VIAL, SINGLE-USE in 1 CARTON (45963-608-68) > 25 mL in 1 VIAL, SINGLE-USE | 2011-11-28 | 2021-06-30 | No | No | Current |