Dexrazoxane
- Product NDC
- 0143-9247
- 11-digit product format
- 001439247
- Labeler code
- 0143
- Product ID
- 0143-9247_032583c8-f4e7-4105-b92e-b5c3f96ca80e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexrazoxane
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA076068
- Marketing category
- ANDA
- Marketing start
- 2005-03-31
- Substance
- DEXRAZOXANE HYDROCHLORIDE
- Active strength
- 250 mg/1
- 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 | 250 mg/1 |
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 |
|---|
| 0143-9247-01 | Dexrazoxane | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 8 |
| 0143-9247-01 | Dexrazoxane | 1 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9247 | DEXRAZOXANE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250125_68089182-d4a2-4053-8d0d-fc97a901515d.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 |
|---|
| 0143-9247-01 | 00143924701 | 1 VIAL in 1 BOX (0143-9247-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1 vial | 2017-10-05 | 0000-00-00 | No | No | Current |