Prescription drug · NDA
Braftovi (Encorafenib) NDC 70255-025
Encorafenib 75 mg/1 · Capsule · Oral · Array BioPharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70255-025-01 | 70255002501 | 2 BOTTLE in 1 CARTON (70255-025-01) / 90 CAPSULE in 1 BOTTLE (70255-025-02)Marketed from Jun 27, 2018 | |
| 70255-025-03 | 70255002503 | 2 BOTTLE in 1 CARTON (70255-025-03) / 60 CAPSULE in 1 BOTTLE (70255-025-04)Marketed from Jun 27, 2018 | |
| 70255-025-05 | 70255002505 | 90 CAPSULE in 1 BOTTLE (70255-025-05)Marketed from Aug 3, 2020 | |
| 70255-025-06 | 70255002506 | 60 CAPSULE in 1 BOTTLE (70255-025-06)Marketed from Aug 3, 2020 |
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)
- Braftovi
- Generic name (nonproprietary)
- encorafenib
- Active ingredients
- Encorafenib — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Array BioPharma Inc.NDC labeler code 70255
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210496
- Marketing start
- Listing expires
- Identifiers
- Product ID 70255-025_7dd6ed01-4c55-49ef-b55d-6d82c5dfc02eSPL ID 7dd6ed01-4c55-49ef-b55d-6d82c5dfc02eSPL set ID 235dfc38-0f0b-4037-b501-7a9f4294740cRxCUI 2049119, 2049121UNII 8L7891MRB6UPC 0370255025067, 0370255025029
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470255002501followed by a unit qualifier and the quantityPackage 70255-0025-01. 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)
BRAFTOVI is a kinase inhibitor indicated: Melanoma • in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test. ( 1.1 , 2.1 ) Colorectal Cancer (CRC) • in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA‑authorized test. ( 1.2 , 2.1 ) • in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA-authorized test, after prior therapy. ( 1.2 , 2.1 ) Non-Small Cell Lung C…
Excerpt only. Read the full label for complete information.
About NDC 70255-025
- What is NDC 70255-025?
- 70255-025 is the product NDC for Braftovi (encorafenib), Encorafenib 75 mg/1 capsule, listed with the FDA by Array BioPharma Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Braftovi (Encorafenib).
- What is the active ingredient?
- Encorafenib.
- Who is the labeler?
- Array BioPharma Inc., NDC labeler code 70255. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Braftovi?
- 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.