Sodium Iodide I 131 Diagnostic NDC 65174-461

NDC codes

FDA NDC Directory

Product NDC (as listed)65174-461Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65174-0461Add 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
65174-461-05	65174046105	5 CAPSULE in 1 VIAL (65174-461-05)Marketed from May 1, 2006

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Sodium Iodide I 131 Diagnostic
Generic name (nonproprietary): sodium iodide i 131
Active ingredients: Sodium iodide i-131 — 100 mCi/1
Dosage form: Capsule
Route: Oral
Labeler: Jubilant DraxImage Inc., dba Jubilant Radiopharma
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021305
Marketing start: May 1, 2006
Listing expires: Dec 31, 2026
Other FDA classes: Radiopharmaceutical Activity (Mechanism)
Identifiers: Product ID 65174-461_6dfea844-f0a4-4485-b898-399267cccc2dSPL ID 6dfea844-f0a4-4485-b898-399267cccc2dSPL set ID 46b8d7ba-432d-d610-84f2-550bf9d0bae3UNII 29VCO8ACHH
Pharmacologic class: Radioactive Therapeutic 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N465174046105 followed by a unit qualifier and the quantity

Package 65174-0461-05. 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 Aug 25, 2020.

Indications (excerpt from the label)

Sodium Iodide I 131 Capsules Diagnostic is indicated for use in adults for: Assessment of thyroid function using radioactive iodine (RAI) uptake test Imaging the thyroid (scintigraphy) Sodium Iodide I 131 Capsules Diagnostic is a radioactive diagnostic agent indicated for the assessment of thyroid function and for thyroid imaging.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021305

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

FDA NDC Directory listings under NDA 021305
Product	Strength	Form · route	Labeler	Product NDC
Hiconsodium iodide i 131	Sodium iodide i-131 1000 mCi/mL	SolutionOral	Jubilant DraxImage Inc., dba Jubilant Radiopharma	65174-880

Sodium Iodide I 131 Diagnostic (sodium iodide i 131) NDC 65174-461