litfulo

Generic: ritlecitinib

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name litfulo
Generic Name ritlecitinib
Labeler pfizer laboratories div pfizer inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

ritlecitinib tosylate 50 mg/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0334
Product ID 0069-0334_fe9562e3-8bb4-46e9-b8f3-9192fabad7a2
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 00690334
Hyphenated Format 0069-0334

Supplemental Identifiers

RxCUI
2641601 2641607
UPC
0300690334288
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 (0069-0334-28)
source: ndc

Packages (1)

0069-0334-28 28 CAPSULE in 1 BOTTLE (0069-0334-28)

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": "fe9562e3-8bb4-46e9-b8f3-9192fabad7a2", "openfda": {"upc": ["0300690334288"], "unii": ["EAG4T1459K"], "rxcui": ["2641601", "2641607"], "spl_set_id": ["6b2f9446-fb23-4741-b73a-5a2f993733c3"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 BOTTLE (0069-0334-28)", "package_ndc": "0069-0334-28", "marketing_start_date": "20230706"}], "brand_name": "Litfulo", "product_id": "0069-0334_fe9562e3-8bb4-46e9-b8f3-9192fabad7a2", "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": "0069-0334", "generic_name": "ritlecitinib", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "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"}