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NDC 43598-0458-36 sorafenib 200 mg/1 Details
sorafenib 200 mg/1
sorafenib is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dr.Reddys Laboratories Inc. The primary component is SORAFENIB TOSYLATE.
MedlinePlus Drug Summary
Sorafenib is used to treat advanced renal cell carcinoma (RCC; a type of cancer that begins in the kidneys). Sorafenib is also used to treat hepatocellular carcinoma (a type of liver cancer) that cannot be treated with surgery and a certain type of thyroid cancer that has spread to other parts of the body and cannot be treated with radioactive iodine. Sorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.
Related Packages: 43598-0458-36Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Sorafenib
Product Information
| NDC | 43598-0458 |
|---|---|
| Product ID | 43598-458_8ad2e151-bfb3-30bc-f24b-928f5f626f1d |
| Associated GPIs | 21533060400320 |
| GCN Sequence Number | 060199 |
| GCN Sequence Number Description | sorafenib tosylate TABLET 200 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 26263 |
| HICL Sequence Number | 033400 |
| HICL Sequence Number Description | SORAFENIB TOSYLATE |
| Brand/Generic | Generic |
| Proprietary Name | sorafenib |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sorafenib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | SORAFENIB TOSYLATE |
| Labeler Name | Dr.Reddys Laboratories Inc |
| Pharmaceutical Class | Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA216073 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43598-0458-36 (43598045836)
| NDC Package Code | 43598-458-36 |
|---|---|
| Billing NDC | 43598045836 |
| Package | 360 TABLET, FILM COATED in 1 BOTTLE (43598-458-36) |
| Marketing Start Date | 2022-06-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |