sotyktu

Generic: deucravacitinib

Labeler: e.r. squibb & sons, l.l.c.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotyktu
Generic Name deucravacitinib
Labeler e.r. squibb & sons, l.l.c.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

deucravacitinib 6 mg/1

Manufacturer
E.R. Squibb & Sons, L.L.C.

Identifiers & Regulatory

Product NDC 0003-0895
Product ID 0003-0895_ff4d7258-5068-4cdf-9692-8cae04c3198e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214958
Listing Expiration 2026-12-31
Marketing Start 2022-09-09

Pharmacologic Class

Established (EPC)
tyrosine kinase 2 inhibitor [epc]
Mechanism of Action
tyrosine kinase 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00030895
Hyphenated Format 0003-0895

Supplemental Identifiers

RxCUI
2612092 2612098
UNII
N0A21N6RAU
NUI
N0000194043 N0000194044

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 sotyktu (source: ndc)
Generic Name deucravacitinib (source: ndc)
Application Number NDA214958 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0895-11)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (0003-0895-91)
source: ndc

Packages (2)

0003-0895-11 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0895-11) 0003-0895-91 30 TABLET, FILM COATED in 1 BLISTER PACK (0003-0895-91)

Ingredients (1)

deucravacitinib (6 mg/1)

Linked Drug Pages (1)

SOTYKTU ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ff4d7258-5068-4cdf-9692-8cae04c3198e", "openfda": {"nui": ["N0000194043", "N0000194044"], "unii": ["N0A21N6RAU"], "rxcui": ["2612092", "2612098"], "spl_set_id": ["ff4d7258-5068-4cdf-9692-8cae04c3198e"], "pharm_class_epc": ["Tyrosine Kinase 2 Inhibitor [EPC]"], "pharm_class_moa": ["Tyrosine Kinase 2 Inhibitors [MoA]"], "manufacturer_name": ["E.R. Squibb & Sons, L.L.C."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0895-11)", "package_ndc": "0003-0895-11", "marketing_start_date": "20220909"}, {"sample": true, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (0003-0895-91)", "package_ndc": "0003-0895-91", "marketing_start_date": "20220909"}], "brand_name": "SOTYKTU", "product_id": "0003-0895_ff4d7258-5068-4cdf-9692-8cae04c3198e", "dosage_form": "TABLET, FILM COATED", "product_ndc": "0003-0895", "generic_name": "deucravacitinib", "labeler_name": "E.R. Squibb & Sons, L.L.C.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SOTYKTU", "active_ingredients": [{"name": "DEUCRAVACITINIB", "strength": "6 mg/1"}], "application_number": "NDA214958", "marketing_category": "NDA", "marketing_start_date": "20220909", "listing_expiration_date": "20261231"}