Prescription drug · NDA
Litfulo (Ritlecitinib) NDC 63539-334
Ritlecitinib tosylate 50 mg/1 · Capsule · Oral · U.S. Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63539-334-28 | 6353903342863539033428 | 28 CAPSULE in 1 BOTTLE (63539-334-28)Marketed from Jul 6, 2023 · Sample package |
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)
- Litfulo
- Generic name (nonproprietary)
- ritlecitinib
- Active ingredients
- Ritlecitinib tosylate — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- U.S. PharmaceuticalsNDC labeler code 63539
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215830
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Janus Kinase 3 Inhibitors (Mechanism)Tyrosine Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 63539-334_6845750b-223c-45ae-bdf3-848d9cef0098SPL ID 6845750b-223c-45ae-bdf3-848d9cef0098SPL set ID 1882f799-61b0-4813-965a-4910c4ae419cRxCUI 2641601, 2641607UNII EAG4T1459K
- 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
N463539033428followed by a unit qualifier and the quantityPackage 63539-0334-28. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. ( 1 ) Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 63539-334
- What is NDC 63539-334?
- 63539-334 is the product NDC for Litfulo (ritlecitinib), Ritlecitinib tosylate 50 mg/1 capsule, listed with the FDA by U.S. Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Litfulo (Ritlecitinib).
- What is the active ingredient?
- Ritlecitinib tosylate.
- Who is the labeler?
- U.S. Pharmaceuticals, NDC labeler code 63539. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Litfulo?
- 1 other product NDC are listed under this name. See all Litfulo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Litfulo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Litfuloritlecitinib | Ritlecitinib tosylate 50 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-0334 | 00069-0334-28 |
Other NDCs under NDA 215830
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 |
|---|---|---|---|---|
| Litfuloritlecitinib | Ritlecitinib tosylate 50 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-0334 |