Dexrazoxane
- Product NDC
- 47781-578
- 11-digit product format
- 477810578
- Labeler code
- 47781
- Product ID
- 47781-578_7077dd4e-5f6a-dd33-8d9a-a3f7f2fbac6f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexrazoxane for Injection
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Alvogen Inc.
- Application
- ANDA207321
- Marketing category
- ANDA
- Marketing start
- 2017-09-01
- Marketing end
- 2021-12-01
- Substance
- DEXRAZOXANE HYDROCHLORIDE
- Active strength
- 500 mg/50mL
- Pharmacologic classes
- Cytoprotective Agent [EPC]
- 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 |
|---|
| 47781-578-07 | 47781057807 | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-578-07) > 50 mL in 1 VIAL, SINGLE-DOSE | 2017-09-01 | 2021-12-01 | No | No | Current |