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NDC 00310-0482-30 IRESSA 250 mg/1 Details
IRESSA 250 mg/1
IRESSA is a ORAL TABLET, COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AstraZeneca Pharmaceuticals LP. The primary component is GEFITINIB.
MedlinePlus Drug Summary
Gefitinib is used to treat non-small cell lung cancer that has spread to other parts of the body in people with certain types of tumors. Gefitinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply.
Related Packages: 00310-0482-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Gefitinib
Product Information
| NDC | 00310-0482 |
|---|---|
| Product ID | 0310-0482_e45a64d1-6585-4489-b601-db5b7e40ad5e |
| Associated GPIs | 21360030000320 |
| GCN Sequence Number | 052086 |
| GCN Sequence Number Description | gefitinib TABLET 250 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 19586 |
| HICL Sequence Number | 025178 |
| HICL Sequence Number Description | GEFITINIB |
| Brand/Generic | Brand |
| Proprietary Name | IRESSA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Gefitinib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 250 |
| Active Ingredient Units | mg/1 |
| Substance Name | GEFITINIB |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Pharmaceutical Class | Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA206995 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00310-0482-30 (00310048230)
| NDC Package Code | 0310-0482-30 |
|---|---|
| Billing NDC | 00310048230 |
| Package | 30 TABLET, COATED in 1 BOTTLE (0310-0482-30) |
| Marketing Start Date | 2015-07-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |