Fluorodopa F18 NDC 13267-346

NDC codes

FDA NDC Directory

Product NDC (as listed)13267-346Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13267-0346Add 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
13267-346-57	13267034657	30 mL in 1 VIAL, GLASS (13267-346-57)Marketed from Oct 10, 2019

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): Fluorodopa F18Suffix: F18
Generic name (nonproprietary): fluorodopa f18
Active ingredients: Fluorodopa f-18 — 40 mCi/mL
Dosage form: Injection
Route: Intravenous
Labeler: THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 200655
Marketing start: Oct 10, 2019
Listing expires: Dec 31, 2026
Identifiers: Product ID 13267-346_f8d69c66-d9aa-4bb8-bb56-5bebeef87af5SPL ID f8d69c66-d9aa-4bb8-bb56-5bebeef87af5SPL set ID 37f8c405-ccb6-4fcd-8513-108956bb1674UNII 2C598205QX

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

N413267034657 followed by a unit qualifier and the quantity

Package 13267-0346-57. 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 Jan 15, 2021.

Indications (excerpt from the label)

Fluorodopa F 18 Injection is indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations. Fluorodopa F 18 Injection is a radioactive diagnostic agent indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 200655

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

FDA NDC Directory listings under NDA 200655
Product	Strength	Form · route	Labeler	Product NDC
Fluorodopa F18	Fluorodopa f-18 8.33 mCi/mL	InjectionIntravenous	THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH	13267-345