Prescription drug · NDA
Vyalev (Foscarbidopa/foslevodopa) NDC 0074-0501
Foscarbidopa 12 mg/mL; Foslevodopa 240 mg/mL · Injection · Subcutaneous · AbbVie Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0074-0501-01 | 00074050101 | 7 VIAL, SINGLE-DOSE in 1 CARTON (0074-0501-01) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 12, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Vyalev
- Generic name (nonproprietary)
- foscarbidopa/foslevodopa
- Active ingredients
- Foscarbidopa — 12 mg/mLFoslevodopa — 240 mg/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- AbbVie Inc.NDC labeler code 0074
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216962
- Marketing start
- Listing expires
- Identifiers
- Product ID 0074-0501_1f0fe652-c027-4b61-9ba4-78548dd48e89SPL ID 1f0fe652-c027-4b61-9ba4-78548dd48e89SPL set ID 28e806e4-951c-40a9-9f0c-d0929caf054cRxCUI 2695782, 2695789UNII 5NT8HCA4OO, 37NQZ0J76I
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
N400074050101followed by a unit qualifier and the quantityPackage 00074-0501-01. 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)
VYALEV is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). VYALEV is a combination of foscarbidopa (an aromatic amino acid decarboxylation inhibitor) and foslevodopa (an aromatic amino acid) indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0074-0501
- What is NDC 0074-0501?
- 0074-0501 is the product NDC for Vyalev (foscarbidopa/foslevodopa), Foscarbidopa 12 mg/mL; Foslevodopa 240 mg/mL injection, listed with the FDA by AbbVie Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vyalev (Foscarbidopa/foslevodopa).
- What is the active ingredient?
- Foscarbidopa, Foslevodopa.
- Who is the labeler?
- AbbVie Inc., NDC labeler code 0074. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vyalev?
- 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.