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NDC 00310-1350-95 TAGRISSO 80 mg/1 Details
TAGRISSO 80 mg/1
TAGRISSO is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AstraZeneca Pharmaceuticals LP. The primary component is OSIMERTINIB.
MedlinePlus Drug Summary
Osimertinib is used to help prevent a certain type of non small-cell lung cancer (NSCLC) from returning after the tumor(s) has been removed by surgery in adults. It is also used as a first treatment for a certain type of NSCLC that has spread to other parts of the body in adults. Osimertinib is also used to treat certain types of NSCLC that has spread to other parts of the body in adults who could not be treated successfully with other similar chemotherapy medications. Osimertinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors.
Related Packages: 00310-1350-95Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Osimertinib
Product Information
| NDC | 00310-1350 |
|---|---|
| Product ID | 0310-1350_d413d9fe-c54c-4c40-9c73-796f96f3edb0 |
| Associated GPIs | 21360068200330 |
| GCN Sequence Number | 075147 |
| GCN Sequence Number Description | osimertinib mesylate TABLET 80 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 40133 |
| HICL Sequence Number | 042803 |
| HICL Sequence Number Description | OSIMERTINIB MESYLATE |
| Brand/Generic | Brand |
| Proprietary Name | TAGRISSO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | osimertinib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 80 |
| Active Ingredient Units | mg/1 |
| Substance Name | OSIMERTINIB |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Pharmaceutical Class | Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208065 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00310-1350-95 (00310135095)
| NDC Package Code | 0310-1350-95 |
|---|---|
| Billing NDC | 00310135095 |
| Package | 1 BLISTER PACK in 1 CARTON (0310-1350-95) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2019-03-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |