What is NDC 69945-166?

69945-166 is the product NDC for Ioflupane I 123 (ioflupane i-123), Ioflupane i-123 2 mCi/mL injection, solution, listed with the FDA by Curium US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Ioflupane I 123 (Ioflupane i-123).

Curium US LLC, NDC labeler code 69945. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ioflupane I 123?

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.

Ioflupane I 123 NDC 69945-166 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69945-166Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69945-0166Add 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
69945-166-05	6994501660569945016605	2.5 mL in 1 VIAL, SINGLE-DOSE (69945-166-05)Marketed from Mar 31, 2022

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): Ioflupane I 123
Generic name (nonproprietary): ioflupane i-123
Active ingredients: Ioflupane i-123 — 2 mCi/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Curium US LLCNDC labeler code 69945
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213792
Marketing start: Mar 31, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Radiopharmaceutical Activity (Mechanism)
Identifiers: Product ID 69945-166_c6a56613-3636-4736-bdaf-db89d8a8448bSPL ID c6a56613-3636-4736-bdaf-db89d8a8448bSPL set ID 66d20aee-4530-48dd-a483-ed7604b36d97UNII 3MM99T8R5Q
Pharmacologic class: Radioactive Diagnostic 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

N469945016605 followed by a unit qualifier and the quantity

Package 69945-0166-05. 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 Dec 16, 2022.

Indications (excerpt from the label)

Ioflupane I 123 Injection is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: ● suspected Parkinsonian syndromes (PS) or ● suspected dementia with Lewy bodies (DLB). Ioflupane I 123 Injection is a radioactive diagnostic agent indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69945-166

What is NDC 69945-166?: 69945-166 is the product NDC for Ioflupane I 123 (ioflupane i-123), Ioflupane i-123 2 mCi/mL injection, solution, listed with the FDA by Curium US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ioflupane I 123 (Ioflupane i-123).
What is the active ingredient?: Ioflupane i-123.
Who is the labeler?: Curium US LLC, NDC labeler code 69945. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ioflupane I 123?: 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.

Ioflupane I 123 (Ioflupane i-123) NDC 69945-166