klisyri

Generic: tirbanibulin

Labeler: almirall, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name klisyri
Generic Name tirbanibulin
Labeler almirall, llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

tirbanibulin 10 mg/g

Manufacturer
Almirall, LLC

Identifiers & Regulatory

Product NDC 16110-391
Product ID 16110-391_89dd936d-4a69-4c60-b743-dfefb589ec1a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213189
Listing Expiration 2026-12-31
Marketing Start 2020-12-14

Pharmacologic Class

Established (EPC)
microtubule inhibitor [epc]
Physiologic Effect
microtubule inhibition [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16110391
Hyphenated Format 16110-391

Supplemental Identifiers

RxCUI
2471095 2471100
UPC
0316110391052 0316110391557
UNII
4V9848RS5G
NUI
N0000175085 N0000175592

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 klisyri (source: ndc)
Generic Name tirbanibulin (source: ndc)
Application Number NDA213189 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 5 PACKET in 1 CARTON (16110-391-05) / .25 g in 1 PACKET
  • 5 PACKET in 1 CARTON (16110-391-55) / .35 g in 1 PACKET
source: ndc

Packages (2)

16110-391-05 5 PACKET in 1 CARTON (16110-391-05) / .25 g in 1 PACKET 16110-391-55 5 PACKET in 1 CARTON (16110-391-55) / .35 g in 1 PACKET

Ingredients (1)

tirbanibulin (10 mg/g)

Linked Drug Pages (1)

Klisyri ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "89dd936d-4a69-4c60-b743-dfefb589ec1a", "openfda": {"nui": ["N0000175085", "N0000175592"], "upc": ["0316110391052", "0316110391557"], "unii": ["4V9848RS5G"], "rxcui": ["2471095", "2471100"], "spl_set_id": ["589c8de8-b773-4d47-b60c-48471806cccc"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Almirall, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 PACKET in 1 CARTON (16110-391-05)  / .25 g in 1 PACKET", "package_ndc": "16110-391-05", "marketing_start_date": "20201214"}, {"sample": false, "description": "5 PACKET in 1 CARTON (16110-391-55)  / .35 g in 1 PACKET", "package_ndc": "16110-391-55", "marketing_start_date": "20240607"}], "brand_name": "Klisyri", "product_id": "16110-391_89dd936d-4a69-4c60-b743-dfefb589ec1a", "dosage_form": "OINTMENT", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "16110-391", "generic_name": "tirbanibulin", "labeler_name": "Almirall, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Klisyri", "active_ingredients": [{"name": "TIRBANIBULIN", "strength": "10 mg/g"}], "application_number": "NDA213189", "marketing_category": "NDA", "marketing_start_date": "20201214", "listing_expiration_date": "20261231"}