Prescription drug · NDA
Zokinvy (Lonafarnib) NDC 42358-475
Lonafarnib 75 mg/1 · Capsule · Oral · Sentynl Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42358-475-30 | 42358047530 | 1 BOTTLE, PLASTIC in 1 CARTON (42358-475-30) / 30 CAPSULE in 1 BOTTLE, PLASTICMarketed from Jul 2, 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)
- Zokinvy
- Generic name (nonproprietary)
- lonafarnib
- Active ingredients
- Lonafarnib — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Sentynl Therapeutics, Inc.NDC labeler code 42358
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213969
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Farnesyltransferase Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 42358-475_027cd79f-a9a2-4038-9296-1f85299b55c5SPL ID 027cd79f-a9a2-4038-9296-1f85299b55c5SPL set ID 97391d0c-943e-4c5a-8423-68e163aa7f50RxCUI 2467582, 2467588, 2467590, 2467592UNII IOW153004FUPC 0342358450305, 0342358475308
- Pharmacologic class
- Farnesyltransferase 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
N442358047530followed by a unit qualifier and the quantityPackage 42358-0475-30. 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)
ZOKINVY is indicated in patients 12 months of age and older with a body surface area (BSA) of 0.39 m 2 and above: To reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS) For the treatment of processing-deficient Progeroid Laminopathies with either: Heterozygous LMNA mutation with progerin-like protein accumulation Homozygous or compound heterozygous ZMPSTE24 mutations ZOKINVY is a farnesyltransferase inhibitor indicated in patients 12 months of age and older with a body surface area of 0.39 m 2 and above: ( 1 ) To reduce risk of mortality in Hutchinson-Gilford Progeria Syndrome. For treatment of processing-deficient Progeroid Laminopathies with either: Heterozygous LMN…
Excerpt only. Read the full label for complete information.
About NDC 42358-475
- What is NDC 42358-475?
- 42358-475 is the product NDC for Zokinvy (lonafarnib), Lonafarnib 75 mg/1 capsule, listed with the FDA by Sentynl Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zokinvy (Lonafarnib).
- What is the active ingredient?
- Lonafarnib.
- Who is the labeler?
- Sentynl Therapeutics, Inc., NDC labeler code 42358. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zokinvy?
- 1 other product NDC are listed under this name. See all Zokinvy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zokinvy products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zokinvylonafarnib | Lonafarnib 50 mg/1 | CapsuleOral | Sentynl Therapeutics, Inc. | 42358-450 | 42358-0450-30 |
Other NDCs under NDA 213969
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 |
|---|---|---|---|---|
| Zokinvylonafarnib | Lonafarnib 50 mg/1 | CapsuleOral | Sentynl Therapeutics, Inc. | 42358-450 |