Prescription drug · NDA
Pylarify (Piflufolastat f-18) NDC 71258-022
Piflufolastat f-18 80 mCi/mL · Injection · Intravenous · Progenics Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71258-022-01 | 71258002201 | 50 mL in 1 VIAL, MULTI-DOSE (71258-022-01)Marketed from May 26, 2021 |
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)
- Pylarify
- Generic name (nonproprietary)
- piflufolastat f-18
- Active ingredients
- Piflufolastat f-18 — 80 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Progenics Pharmaceuticals, Inc.NDC labeler code 71258
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214793
- Marketing start
- Listing expires
- Other FDA classes
- Positron Emitting Activity (Mechanism)
- Identifiers
- Product ID 71258-022_db2acb00-3e3b-4ecc-b532-08e456075404SPL ID db2acb00-3e3b-4ecc-b532-08e456075404SPL set ID a00e5cbc-4fd5-4280-82ec-cd3498df4553UNII 3934EF02T7
- 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
N471258002201followed by a unit qualifier and the quantityPackage 71258-0022-01. 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)
PYLARIFY 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. PYLARIFY 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 71258-022
- What is NDC 71258-022?
- 71258-022 is the product NDC for Pylarify (piflufolastat f-18), Piflufolastat f-18 80 mCi/mL injection, listed with the FDA by Progenics Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pylarify (Piflufolastat f-18).
- What is the active ingredient?
- Piflufolastat f-18.
- Who is the labeler?
- Progenics Pharmaceuticals, Inc., NDC labeler code 71258. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pylarify?
- 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.