What is NDC 0517-9305?

0517-9305 is the product NDC for Tralement (trace elements injection 4), Zinc sulfate 3 mg/mL + 3 more ingredients injection, solution, listed with the FDA by American Regent, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Tralement (Trace Elements Injection 4).

What is the active ingredient?

Zinc sulfate, Cupric sulfate, Manganese sulfate, Selenious acid.

American Regent, Inc., NDC labeler code 0517. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tralement?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tralement NDC 0517-9305 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0517-9305Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00517-9305Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0517-9305-25	0051793052500517930525	25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9305-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-9305-01)Marketed from Sep 29, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Tralement
Generic name (nonproprietary): trace elements injection 4
Active ingredients: Zinc sulfate — 3 mg/mLCupric sulfate — .3 mg/mLManganese sulfate — 55 ug/mLSelenious acid — 60 ug/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: American Regent, Inc.NDC labeler code 0517
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 209376
Marketing start: Sep 29, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Copper Ion Absorption (Physiologic effect)Magnetic Resonance Contrast Activity (Mechanism)
Identifiers: Product ID 0517-9305_98253bed-5ff4-478f-aff5-c35944fad08aSPL ID 98253bed-5ff4-478f-aff5-c35944fad08aSPL set ID a49ffb90-f307-433e-a86e-aaea6d6a9982RxCUI 2693627, 2693633UNII 89DS0H96TB, LRX7AJ16DT, W00LYS4T26, F6A27P4Q4RUPC 0305178201250
Pharmacologic class: Copper Absorption Inhibitor; Paramagnetic Contrast Agent

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400517930525 followed by a unit qualifier and the quantity

Package 00517-9305-25. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jul 1, 2024.

Indications (excerpt from the label)

Tralement ® is indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Tralement is a combination of trace elements (zinc sulfate, cupric sulfate, manganese sulfate and selenious acid) indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0517-9305

What is NDC 0517-9305?: 0517-9305 is the product NDC for Tralement (trace elements injection 4), Zinc sulfate 3 mg/mL + 3 more ingredients injection, solution, listed with the FDA by American Regent, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tralement (Trace Elements Injection 4).
What is the active ingredient?: Zinc sulfate, Cupric sulfate, Manganese sulfate, Selenious acid.
Who is the labeler?: American Regent, Inc., NDC labeler code 0517. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tralement?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 209376

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 209376
Product	Strength	Form · route	Labeler	Product NDC
Multrystrace elements injection 4	Zinc sulfate 2470 ug/mL + 3 more ingredients	Injection, SolutionIntravenous	American Regent, Inc.	0517-9302

Tralement (Trace elements injection 4) NDC 0517-9305