tralement

Generic: trace elements injection 4

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tralement
Generic Name trace elements injection 4
Labeler american regent, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cupric sulfate .3 mg/mL, manganese sulfate 55 ug/mL, selenious acid 60 ug/mL, zinc sulfate 3 mg/mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-9305
Product ID 0517-9305_4a6d8c5d-729c-45b3-b565-2e10e0cbcaaf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209376
Listing Expiration 2026-12-31
Marketing Start 2020-09-29

Pharmacologic Class

Classes
copper absorption inhibitor [epc] decreased copper ion absorption [pe] magnetic resonance contrast activity [moa] paramagnetic contrast agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05179305
Hyphenated Format 0517-9305

Supplemental Identifiers

RxCUI
2693627 2693633
UPC
0305178201250
UNII
LRX7AJ16DT W00LYS4T26 F6A27P4Q4R 89DS0H96TB

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tralement (source: ndc)
Generic Name trace elements injection 4 (source: ndc)
Application Number NDA209376 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .3 mg/mL
  • 55 ug/mL
  • 60 ug/mL
  • 3 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9305-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-9305-01)
source: ndc

Packages (1)

0517-9305-25 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9305-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-9305-01)

Ingredients (4)

cupric sulfate (.3 mg/mL) manganese sulfate (55 ug/mL) selenious acid (60 ug/mL) zinc sulfate (3 mg/mL)

Linked Drug Pages (1)

Tralement ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4a6d8c5d-729c-45b3-b565-2e10e0cbcaaf", "openfda": {"upc": ["0305178201250"], "unii": ["LRX7AJ16DT", "W00LYS4T26", "F6A27P4Q4R", "89DS0H96TB"], "rxcui": ["2693627", "2693633"], "spl_set_id": ["a49ffb90-f307-433e-a86e-aaea6d6a9982"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9305-25)  / 1 mL in 1 VIAL, SINGLE-DOSE (0517-9305-01)", "package_ndc": "0517-9305-25", "marketing_start_date": "20200929"}], "brand_name": "Tralement", "product_id": "0517-9305_4a6d8c5d-729c-45b3-b565-2e10e0cbcaaf", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]", "Magnetic Resonance Contrast Activity [MoA]", "Paramagnetic Contrast Agent [EPC]"], "product_ndc": "0517-9305", "generic_name": "Trace Elements Injection 4", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tralement", "active_ingredients": [{"name": "CUPRIC SULFATE", "strength": ".3 mg/mL"}, {"name": "MANGANESE SULFATE", "strength": "55 ug/mL"}, {"name": "SELENIOUS ACID", "strength": "60 ug/mL"}, {"name": "ZINC SULFATE", "strength": "3 mg/mL"}], "application_number": "NDA209376", "marketing_category": "NDA", "marketing_start_date": "20200929", "listing_expiration_date": "20261231"}