odomzo

Generic: sonidegib

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name odomzo
Generic Name sonidegib
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

sonidegib phosphate 200 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-303
Product ID 47335-303_001dc6f2-7476-4ffd-8ea4-be2f97a2b6b3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205266
Listing Expiration 2026-12-31
Marketing Start 2017-09-21

Pharmacologic Class

Classes
hedgehog pathway inhibitor [epc] smoothened receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335303
Hyphenated Format 47335-303

Supplemental Identifiers

RxCUI
1659921 1659927
UNII
W421AI34UW

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 odomzo (source: ndc)
Generic Name sonidegib (source: ndc)
Application Number NDA205266 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (47335-303-15)
  • 30 CAPSULE in 1 BOTTLE (47335-303-83)
source: ndc

Packages (2)

47335-303-15 30 CAPSULE in 1 BOTTLE (47335-303-15) 47335-303-83 30 CAPSULE in 1 BOTTLE (47335-303-83)

Ingredients (1)

sonidegib phosphate (200 mg/1)

Linked Drug Pages (1)

Odomzo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "001dc6f2-7476-4ffd-8ea4-be2f97a2b6b3", "openfda": {"unii": ["W421AI34UW"], "rxcui": ["1659921", "1659927"], "spl_set_id": ["028312dc-d155-4fd5-8abd-6bb9f011d3cc"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (47335-303-15)", "package_ndc": "47335-303-15", "marketing_start_date": "20170921"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (47335-303-83)", "package_ndc": "47335-303-83", "marketing_start_date": "20170921"}], "brand_name": "Odomzo", "product_id": "47335-303_001dc6f2-7476-4ffd-8ea4-be2f97a2b6b3", "dosage_form": "CAPSULE", "pharm_class": ["Hedgehog Pathway Inhibitor [EPC]", "Smoothened Receptor Antagonists [MoA]"], "product_ndc": "47335-303", "generic_name": "sonidegib", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Odomzo", "active_ingredients": [{"name": "SONIDEGIB PHOSPHATE", "strength": "200 mg/1"}], "application_number": "NDA205266", "marketing_category": "NDA", "marketing_start_date": "20170921", "listing_expiration_date": "20261231"}