Prescription drug · NDA
Ojemda (Tovorafenib) NDC 82950-001
Tovorafenib 100 mg/1 · Tablet, Film coated · Oral · Day One Biopharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82950-001-16 | 82950000116 | 4 BLISTER PACK in 1 CARTON (82950-001-16) / 4 TABLET, FILM COATED in 1 BLISTER PACK (82950-001-04)Marketed from Apr 30, 2024 | |
| 82950-001-20 | 82950000120 | 4 BLISTER PACK in 1 CARTON (82950-001-20) / 5 TABLET, FILM COATED in 1 BLISTER PACK (82950-001-05)Marketed from Apr 30, 2025 | |
| 82950-001-24 | 82950000124 | 4 BLISTER PACK in 1 CARTON (82950-001-24) / 6 TABLET, FILM COATED in 1 BLISTER PACK (82950-001-06)Marketed from Apr 30, 2024 |
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)
- Ojemda
- Generic name (nonproprietary)
- tovorafenib
- Active ingredients
- Tovorafenib — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Day One Biopharmaceuticals, Inc.NDC labeler code 82950
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217700
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A Inducers (Mechanism)Type II RAF Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 82950-001_8bee41f8-a2d9-44ae-82a9-bd46b6f9916aSPL ID 8bee41f8-a2d9-44ae-82a9-bd46b6f9916aSPL set ID ea3a9631-3a66-6a7c-e053-2995a90ae2adRxCUI 2682439, 2682445, 2682450, 2682454, 2690857, 2690858, 2690859, 2690860, 2690861, 2690862UNII ZN90E4027M
- Pharmacologic class
- Kinase Inhibitor
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
N482950000116followed by a unit qualifier and the quantityPackage 82950-0001-16. 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)
OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on 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(s). OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. ( 1 )…
Excerpt only. Read the full label for complete information.
About NDC 82950-001
- What is NDC 82950-001?
- 82950-001 is the product NDC for Ojemda (tovorafenib), Tovorafenib 100 mg/1 tablet, film coated, listed with the FDA by Day One Biopharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ojemda (Tovorafenib).
- What is the active ingredient?
- Tovorafenib.
- Who is the labeler?
- Day One Biopharmaceuticals, Inc., NDC labeler code 82950. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ojemda?
- 1 other product NDC are listed under this name. See all Ojemda NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ojemda products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ojemdatovorafenib | — | Kit | Day One Biopharmaceuticals, Inc. | 82950-012 | 82950-0012-01 |