Dexrazoxane
- Product NDC
- 68083-195
- 11-digit product format
- 680830195
- Labeler code
- 68083
- Product ID
- 68083-195_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
- 2016-12-05
- Substance
- DEXRAZOXANE HYDROCHLORIDE
- Active strength
- 500 mg/50mL
- Pharmacologic classes
- Cytoprotective Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexrazoxane
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXRAZOXANE HYDROCHLORIDE | 500 mg/50mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5346058Q7S |
| Rxcui | 1736585, 1736590 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-195-01 | Dexrazoxane | 50 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 50 | | 6 |
| 68083-195-01 | Dexrazoxane | 01 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 01 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-195 | DEXRAZOXANE (DEXRAZOXANE FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] | 5 | Current NDC, Legacy NDC, 2 package rows | 20231214_c9c625fc-8852-4ed4-bcf2-63f46a706782.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 |
|---|
| 68083-195-01 | 68083019501 | 1 VIAL in 1 CARTON (68083-195-01) / 50 mL in 1 VIAL | 1 vial | 2016-12-05 | 0000-00-00 | No | No | Current |