Prescription drug · NDA
Avmapki Fakzynja Co-Pack NDC 71779-623
avutometinib potassium and defactinib hydrochloride · Kit · Verastem Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71779-623-01 | 71779062301 | 1 KIT in 1 CARTON (71779-623-01) * 24 CAPSULE in 1 BOTTLE (71779-660-02) * 42 TABLET in 1 BOTTLE (71779-630-01)Marketed from May 8, 2025 |
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)
- Avmapki Fakzynja Co-Pack
- Generic name (nonproprietary)
- avutometinib potassium and defactinib hydrochloride
- Dosage form
- Kit
- Labeler
- Verastem Inc.NDC labeler code 71779
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219616
- Marketing start
- Listing expires
- Identifiers
- Product ID 71779-623_e6def323-179c-432e-957d-fc4ea03e1b78SPL ID e6def323-179c-432e-957d-fc4ea03e1b78SPL set ID 65889527-1406-45df-8a85-e2690dcf427dRxCUI 2714507, 2714513, 2714520, 2714526, 2714921, 2714922
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.
- NDC on a medical claim
N471779062301followed by a unit qualifier and the quantityPackage 71779-0623-01. 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)
AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. AVMAPKI FAKZYNJA CO-PACK, a combination of avutometinib and defactinib, each kinase inhibitors, is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior sy…
Excerpt only. Read the full label for complete information.
About NDC 71779-623
- What is NDC 71779-623?
- 71779-623 is the product NDC for Avmapki Fakzynja Co-Pack kit, listed with the FDA by Verastem Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Avmapki Fakzynja Co-Pack (Avutometinib potassium and defactinib hydrochloride).
- Who is the labeler?
- Verastem Inc., NDC labeler code 71779. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Avmapki Fakzynja Co-Pack?
- 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.