litfulo

Generic: ritlecitinib

Labeler: u.s. pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name litfulo
Generic Name ritlecitinib
Labeler u.s. pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

ritlecitinib tosylate 50 mg/1

Manufacturer
U.S. Pharmaceuticals

Identifiers & Regulatory

Product NDC 63539-334
Product ID 63539-334_5f5f631a-94b4-470e-939f-bbe09f204835
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215830
Listing Expiration 2026-12-31
Marketing Start 2023-07-06

Pharmacologic Class

Classes
cytochrome p450 1a2 inhibitors [moa] cytochrome p450 3a inhibitors [moa] janus kinase 3 inhibitors [moa] kinase inhibitor [epc] tyrosine kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63539334
Hyphenated Format 63539-334

Supplemental Identifiers

RxCUI
2641601 2641607
UNII
EAG4T1459K

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name litfulo (source: ndc)
Generic Name ritlecitinib (source: ndc)
Application Number NDA215830 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 BOTTLE (63539-334-28)
source: ndc

Packages (1)

63539-334-28 28 CAPSULE in 1 BOTTLE (63539-334-28)

Ingredients (1)

ritlecitinib tosylate (50 mg/1)

Linked Drug Pages (1)

Litfulo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5f5f631a-94b4-470e-939f-bbe09f204835", "openfda": {"unii": ["EAG4T1459K"], "rxcui": ["2641601", "2641607"], "spl_set_id": ["1882f799-61b0-4813-965a-4910c4ae419c"], "manufacturer_name": ["U.S. Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "28 CAPSULE in 1 BOTTLE (63539-334-28)", "package_ndc": "63539-334-28", "marketing_start_date": "20230706"}], "brand_name": "Litfulo", "product_id": "63539-334_5f5f631a-94b4-470e-939f-bbe09f204835", "dosage_form": "CAPSULE", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Janus Kinase 3 Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Tyrosine Kinase Inhibitors [MoA]"], "product_ndc": "63539-334", "generic_name": "ritlecitinib", "labeler_name": "U.S. Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Litfulo", "active_ingredients": [{"name": "RITLECITINIB TOSYLATE", "strength": "50 mg/1"}], "application_number": "NDA215830", "marketing_category": "NDA", "marketing_start_date": "20230706", "listing_expiration_date": "20261231"}