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NDC 69339-0168-03 Gefitinib 250 mg/1 Details
Gefitinib 250 mg/1
Gefitinib is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Natco Pharma USA LLC. 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: 69339-0168-03Last Updated: 05/05/2024
MedLinePlus Full Drug Details: Gefitinib
Product Information
| NDC | 69339-0168 |
|---|---|
| Product ID | 69339-168_5040d82b-d57a-46c3-a888-414848563438 |
| Associated GPIs | |
| 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 | Generic |
| Proprietary Name | Gefitinib |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Gefitinib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 250 |
| Active Ingredient Units | mg/1 |
| Substance Name | GEFITINIB |
| Labeler Name | Natco Pharma USA LLC |
| Pharmaceutical Class | Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212827 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69339-0168-03 (69339016803)
| NDC Package Code | 69339-168-03 |
|---|---|
| Billing NDC | 69339016803 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE (69339-168-03) |
| Marketing Start Date | 2023-06-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |