Dexrazoxane
- Product NDC
- 72611-716
- 11-digit product format
- 726110716
- Labeler code
- 72611
- Product ID
- 72611-716_04d9a64e-d4e5-22d2-bfef-32594ee380d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexrazoxane for Injection
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Almaject, Inc.
- Application
- ANDA207321
- Marketing category
- ANDA
- Marketing start
- 2022-06-01
- 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 | 1736590 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72611-716-01 | Dexrazoxane | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 50 | | 6 |
| 72611-716-01 | Dexrazoxane | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
| 72611-716-72 | Dexrazoxane | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 50 | | 4 |
| 72611-716-72 | Dexrazoxane | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72611-716 | DEXRAZOXANE (DEXRAZOXANE FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALMAJECT, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241006_e9550d22-6069-a6de-9968-6a18c9e0448f.zip |
| 72611-716 | DEXRAZOXANE (DEXRAZOXANE FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALMAJECT, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241009_9cbd2987-10bb-eceb-153d-ee7be1ed0c84.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72611-716-01 | 72611071601 | 1 VIAL, SINGLE-DOSE in 1 CARTON (72611-716-01) / 50 mL in 1 VIAL, SINGLE-DOSE | 2020-09-01 | 0000-00-00 | No | No | Current |
| 72611-716-72 | 72611071672 | 1 VIAL, SINGLE-DOSE in 1 CARTON (72611-716-72) / 50 mL in 1 VIAL, SINGLE-DOSE | 2022-06-01 | 0000-00-00 | No | No | Current |