Prescription drug · NDA
Posluma (Flotufolastat f-18) NDC 69932-002
Flotufolastat f-18 158 mCi/mL · Injection · Intravenous · Blue Earth Diagnostics
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69932-002-50 | 69932000250 | 25 mL in 1 VIAL, MULTI-DOSE (69932-002-50)Marketed from May 25, 2023 |
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)
- Posluma
- Generic name (nonproprietary)
- flotufolastat f-18
- Active ingredients
- Flotufolastat f-18 — 158 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Blue Earth DiagnosticsNDC labeler code 69932
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216023
- Marketing start
- Listing expires
- Other FDA classes
- Positron Emitting Activity (Mechanism)
- Identifiers
- Product ID 69932-002_67cbcafa-00b3-41fd-986d-1159706273f3SPL ID 67cbcafa-00b3-41fd-986d-1159706273f3SPL set ID 907ac4a4-a088-4826-ab50-cfc31985c9d4UNII 811W19E3OL
- 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.
- NDC on a medical claim
N469932000250followed by a unit qualifier and the quantityPackage 69932-0002-50. 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 .
Indications (excerpt from the label)
POSLUMA is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. POSLUMA is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 69932-002
- What is NDC 69932-002?
- 69932-002 is the product NDC for Posluma (flotufolastat f-18), Flotufolastat f-18 158 mCi/mL injection, listed with the FDA by Blue Earth Diagnostics. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Posluma (Flotufolastat F-18).
- What is the active ingredient?
- Flotufolastat f-18.
- Who is the labeler?
- Blue Earth Diagnostics, NDC labeler code 69932. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Posluma?
- 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.