What is NDC 65857-300?

65857-300 is the product NDC for Sodium Fluoride F18, Sodium fluoride f-18 200 mCi/mL injection, listed with the FDA by Cardinal Health 414, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Cardinal Health 414, LLC, NDC labeler code 65857. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sodium Fluoride F18?

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.

Sodium Fluoride F18 NDC 65857-300 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65857-300Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65857-0300Add 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
65857-300-30	6585703003065857030030	30 mL in 1 VIAL, GLASS (65857-300-30)Marketed from Jul 30, 2015

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 Fluoride F18Suffix: F18
Generic name (nonproprietary): sodium fluoride f18
Active ingredients: Sodium fluoride f-18 — 200 mCi/mL
Dosage form: Injection
Route: Intravenous
Labeler: Cardinal Health 414, LLCNDC labeler code 65857
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203780
Marketing start: Jul 30, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Radiopharmaceutical Activity (Mechanism)
Identifiers: Product ID 65857-300_56810233-d952-4904-a3e9-c3dc3aa480e6SPL ID 56810233-d952-4904-a3e9-c3dc3aa480e6SPL set ID 96e61ba1-30ca-4844-b503-056afd247e69UNII 9L75099X6R
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

N465857030030 followed by a unit qualifier and the quantity

Package 65857-0300-30. 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 Nov 20, 2018.

Indications (excerpt from the label)

Sodium Fluoride F-18 Injection, USP, is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity. Sodium Fluoride F-18 Injection, USP, is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65857-300

What is NDC 65857-300?: 65857-300 is the product NDC for Sodium Fluoride F18, Sodium fluoride f-18 200 mCi/mL injection, listed with the FDA by Cardinal Health 414, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sodium Fluoride F18.
What is the active ingredient?: Sodium fluoride f-18.
Who is the labeler?: Cardinal Health 414, LLC, NDC labeler code 65857. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sodium Fluoride F18?: 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.