Tralement
- Product NDC
- 0517-9305
- 11-digit product format
- 005179305
- Labeler code
- 0517
- Product ID
- 0517-9305_4a6d8c5d-729c-45b3-b565-2e10e0cbcaaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trace Elements Injection 4
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- American Regent, Inc.
- Application
- NDA209376
- Marketing category
- NDA
- Marketing start
- 2020-09-29
- Substance
- CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
- Active strength
- .3; 55; 60; 3 mg/mL; ug/mL; ug/mL; mg/mL
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast 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
- Tralement
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CUPRIC SULFATE | .3 mg/mL |
| MANGANESE SULFATE | 55 ug/mL |
| SELENIOUS ACID | 60 ug/mL |
| ZINC SULFATE | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LRX7AJ16DT, W00LYS4T26, F6A27P4Q4R, 89DS0H96TB |
| Rxcui | 2693627, 2693633 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0517-9305-01 | Tralement | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 9 |
| 0517-9305-25 | Tralement | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0517-9305 | TRALEMENT (TRACE ELEMENTS INJECTION 4) INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240824_a49ffb90-f307-433e-a86e-aaea6d6a9982.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 |
|---|
| 0517-9305-01 | 00517930501 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 0517-9305-25 | 00517930525 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9305-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-9305-01) | | 2020-09-29 | 0000-00-00 | No | No | Current |