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NDC 00517-9305-25 Tralement .3; 55; 60; 3 mg/mL; ug/mL; ug/mL; mg/mL Details
Tralement .3; 55; 60; 3 mg/mL; ug/mL; ug/mL; mg/mL
Tralement is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by American Regent, Inc.. The primary component is CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE.
Product Information
| NDC | 00517-9305 |
|---|---|
| Product ID | 0517-9305_deeb1a5b-de13-4b67-b7c3-7503ca79926f |
| Associated GPIs | 79909904252020 |
| GCN Sequence Number | 081266 |
| GCN Sequence Number Description | zinc/copper/manganese/selenium VIAL 3-0.3MG/ML INTRAVEN |
| HIC3 | C3M |
| HIC3 Description | MINERAL REPLACEMENT, MISCELLANEOUS |
| GCN | 48322 |
| HICL Sequence Number | 046690 |
| HICL Sequence Number Description | ZINC SULFATE/CUPRIC SULFATE/MANGANESE SULFATE/SELENIUM |
| Brand/Generic | Brand |
| Proprietary Name | Tralement |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Trace Elements Injection 4 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | .3; 55; 60; 3 |
| Active Ingredient Units | mg/mL; ug/mL; ug/mL; mg/mL |
| Substance Name | CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE |
| Labeler Name | American Regent, Inc. |
| Pharmaceutical Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA209376 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00517-9305-25 (00517930525)
| NDC Package Code | 0517-9305-25 |
|---|---|
| Billing NDC | 00517930525 |
| Package | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9305-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-9305-01) |
| Marketing Start Date | 2020-09-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |