Litfulo
- Product NDC
- 63539-334
- 11-digit product format
- 635390334
- Labeler code
- 63539
- Product ID
- 63539-334_5f5f631a-94b4-470e-939f-bbe09f204835
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ritlecitinib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- U.S. Pharmaceuticals
- Application
- NDA215830
- Marketing category
- NDA
- Marketing start
- 2023-07-06
- Substance
- RITLECITINIB TOSYLATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Janus Kinase 3 Inhibitors [MoA], Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Litfulo
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RITLECITINIB TOSYLATE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EAG4T1459K |
| Rxcui | 2641601, 2641607 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63539-334-28 | Litfulo | 28 in 1 BOTTLE | CAPSULE | 28 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63539-334 | LITFULO (RITLECITINIB) CAPSULE [U.S. PHARMACEUTICALS] | 2 | Current NDC, 1 package rows | 20250322_1882f799-61b0-4813-965a-4910c4ae419c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63539-334-28 | 63539033428 | 28 CAPSULE in 1 BOTTLE (63539-334-28) | 28 capsule | 2023-07-06 | Yes | No | Current |