Prescription drug · NDA
Ogsiveo (Nirogacestat) NDC 82448-100
Nirogacestat 100 mg/1 · Tablet, Film coated · Oral · SpringWorks Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82448-100-14 | 8244801001482448010014 | 14 TABLET, FILM COATED in 1 BLISTER PACK (82448-100-14)Marketed from Nov 27, 2023 |
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)
- Ogsiveo
- Generic name (nonproprietary)
- nirogacestat
- Active ingredients
- Nirogacestat — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- SpringWorks Therapeutics, Inc.NDC labeler code 82448
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217677
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Gamma Secretase Inhibitors (Mechanism)
- Identifiers
- Product ID 82448-100_a20856d6-9ddc-4e6a-bd63-d19cdcec6a41SPL ID a20856d6-9ddc-4e6a-bd63-d19cdcec6a41SPL set ID f172e6ff-3190-41b0-b95a-58a7ef9e9e1eRxCUI 2680360, 2680362, 2680363, 2680364, 2680366, 2680368, 2680369, 2680370UNII QZ62892OFJ
- Pharmacologic class
- Gamma Secretase 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
N482448010014followed by a unit qualifier and the quantityPackage 82448-0100-14. 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)
OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment. OGSIVEO is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 82448-100
- What is NDC 82448-100?
- 82448-100 is the product NDC for Ogsiveo (nirogacestat), Nirogacestat 100 mg/1 tablet, film coated, listed with the FDA by SpringWorks Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ogsiveo (Nirogacestat).
- What is the active ingredient?
- Nirogacestat.
- Who is the labeler?
- SpringWorks Therapeutics, Inc., NDC labeler code 82448. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ogsiveo?
- 1 other product NDC are listed under this name. See all Ogsiveo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ogsiveo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ogsiveonirogacestat | Nirogacestat 150 mg/1 | Tablet, Film coatedOral | SpringWorks Therapeutics, Inc. | 82448-150 | 82448-0150-14 |
Other NDCs under NDA 217677
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ogsiveonirogacestat | Nirogacestat 150 mg/1 | Tablet, Film coatedOral | SpringWorks Therapeutics, Inc. | 82448-150 |