Search by Drug Name or NDC
NDC 47335-0303-83 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: 47335-0303-83Last Updated: 11/30/2022
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 47335-0303-83 (47335030383)
NDC Package Code | 47335-303-83 |
---|---|
Billing NDC | 47335030383 |
Package | 30 CAPSULE in 1 BOTTLE (47335-303-83) |
Marketing Start Date | 2017-09-21 |
NDC Exclude Flag | N |
Pricing Information | N/A |