scemblix

Generic: asciminib

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name scemblix
Generic Name asciminib
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

asciminib hydrochloride 20 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-1091
Product ID 0078-1091_e187165a-eb84-4ee5-98b8-d4e777ec7b4a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215358
Listing Expiration 2026-12-31
Marketing Start 2021-10-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00781091
Hyphenated Format 0078-1091

Supplemental Identifiers

RxCUI
2584320 2584326 2584328 2584330 2680278 2680280
UPC
0300781098204 0300781091205
UNII
C5U34S9XFV

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 scemblix (source: ndc)
Generic Name asciminib (source: ndc)
Application Number NDA215358 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (0078-1091-20)
  • 14 TABLET, FILM COATED in 1 BOTTLE (0078-1091-94)
source: ndc

Packages (2)

0078-1091-20 60 TABLET, FILM COATED in 1 BOTTLE (0078-1091-20) 0078-1091-94 14 TABLET, FILM COATED in 1 BOTTLE (0078-1091-94)

Ingredients (1)

asciminib hydrochloride (20 mg/1)

Linked Drug Pages (1)

SCEMBLIX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e187165a-eb84-4ee5-98b8-d4e777ec7b4a", "openfda": {"upc": ["0300781098204", "0300781091205"], "unii": ["C5U34S9XFV"], "rxcui": ["2584320", "2584326", "2584328", "2584330", "2680278", "2680280"], "spl_set_id": ["e33001e7-3650-42b1-ae56-cddb5c43aa2b"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (0078-1091-20)", "package_ndc": "0078-1091-20", "marketing_start_date": "20211029"}, {"sample": true, "description": "14 TABLET, FILM COATED in 1 BOTTLE (0078-1091-94)", "package_ndc": "0078-1091-94", "marketing_start_date": "20211029"}], "brand_name": "SCEMBLIX", "product_id": "0078-1091_e187165a-eb84-4ee5-98b8-d4e777ec7b4a", "dosage_form": "TABLET, FILM COATED", "product_ndc": "0078-1091", "generic_name": "asciminib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SCEMBLIX", "active_ingredients": [{"name": "ASCIMINIB HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "NDA215358", "marketing_category": "NDA", "marketing_start_date": "20211029", "listing_expiration_date": "20261231"}