Dexrazoxane
- Product NDC
- 68083-388
- 11-digit product format
- 680830388
- Labeler code
- 68083
- Product ID
- 68083-388_31a8c608-3ad6-44fe-aec8-621a8b991677
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexrazoxane for Injection
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA207321
- Marketing category
- ANDA
- Marketing start
- 2019-12-16
- Substance
- DEXRAZOXANE HYDROCHLORIDE
- Active strength
- 250 mg/25mL
- Pharmacologic classes
- Cytoprotective Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 5346058Q7S | DEXRAZOXANE HYDROCHLORIDE | 1263283-43-7 | DEXRAZOXANE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-388-01 | 68083038801 | 1 VIAL in 1 CARTON (68083-388-01) / 25 mL in 1 VIAL | 1 vial | 2019-12-16 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Dexrazoxane for Injection | Gland Pharma Limited | 2025-06-23 | Human Prescription Drug Label | 6 |