Zokinvy
- Product NDC
- 42358-475
- 11-digit product format
- 423580475
- Labeler code
- 42358
- Product ID
- 42358-475_027cd79f-a9a2-4038-9296-1f85299b55c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lonafarnib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sentynl Therapeutics, Inc.
- Application
- NDA213969
- Marketing category
- NDA
- Marketing start
- 2025-07-02
- Substance
- LONAFARNIB
- Active strength
- 75 mg/1
- Pharmacologic classes
- Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Farnesyltransferase Inhibitor [EPC], Farnesyltransferase Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zokinvy
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LONAFARNIB | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IOW153004F |
| Rxcui | 2467582, 2467588, 2467590, 2467592 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42358-475-30 | Zokinvy | 1 in 1 CARTON | CAPSULE | 1 | | 2 |
| 42358-475-30 | Zokinvy | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42358-475-30 | 42358047530 | 1 BOTTLE, PLASTIC in 1 CARTON (42358-475-30) / 30 CAPSULE in 1 BOTTLE, PLASTIC | 2025-07-02 | No | No | Historical |