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NDC 47335-0303-15 Odomzo 200 mg/1 Details

Odomzo 200 mg/1

Odomzo is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is SONIDEGIB PHOSPHATE.

MedlinePlus Drug Summary

Sonidegib is used to treat basal cell carcinoma (BCC; a type of skin cancer) in adults with cancer that has come back after surgery or radiation, or in adults that cannot be treated with surgery or radiation. Sonidegib is in a class of medications called hedgehog pathway inhibitors. It works by blocking the action of a protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors.

Related Packages: 47335-0303-15
Last Updated: 04/14/2024
MedLinePlus Full Drug Details: Sonidegib

Product Information

NDC	47335-0303
Product ID	47335-303_a2951b0d-10fe-447c-8f83-2c244fbc8815
Associated GPIs	21370060200120
GCN Sequence Number	074547
GCN Sequence Number Description	sonidegib phosphate CAPSULE 200 MG ORAL
HIC3	V3M
HIC3 Description	ANTINEOPLASTIC - HEDGEHOG PATHWAY INHIBITOR
GCN	39217
HICL Sequence Number	042369
HICL Sequence Number Description	SONIDEGIB PHOSPHATE
Brand/Generic	Brand
Proprietary Name	Odomzo
Proprietary Name Suffix	n/a
Non-Proprietary Name	sonidegib
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/1
Substance Name	SONIDEGIB PHOSPHATE
Labeler Name	Sun Pharmaceutical Industries, Inc.
Pharmaceutical Class	Hedgehog Pathway Inhibitor [EPC], Smoothened Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA205266
Listing Certified Through	2025-12-31

Package

NDC 47335-0303-15 (47335030315)

Pricing Information	N/A
NDC Package Code	47335-303-15
Billing NDC	47335030315
Package	30 CAPSULE in 1 BOTTLE (47335-303-15)
Marketing Start Date	2017-09-21
NDC Exclude Flag	N