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NDC 68382-0913-06 Erlotinib 25 mg/1 Details
Erlotinib 25 mg/1
Erlotinib is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is ERLOTINIB HYDROCHLORIDE.
MedlinePlus Drug Summary
Erlotinib is used to treat certain types of non-small cell lung cancer that has spread to nearby tissues or to other parts of the body in patients who have already been treated with at least one other chemotherapy medication and have not gotten better. Erlotinib is also used in combination with another medication (gemcitabine [Gemzar]) to treat pancreatic cancer that has spread to nearby tissues or to other parts of the body and cannot be treated with surgery. Erlotinib 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 slow or stop the spread of cancer cells.
Related Packages: 68382-0913-06Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Erlotinib
Product Information
| NDC | 68382-0913 |
|---|---|
| Product ID | 68382-913_e34fafdf-2fda-4031-9202-6d7e85925dc1 |
| Associated GPIs | 21360025100320 |
| GCN Sequence Number | 058376 |
| GCN Sequence Number Description | erlotinib HCl TABLET 25 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 23795 |
| HICL Sequence Number | 026745 |
| HICL Sequence Number Description | ERLOTINIB HCL |
| Brand/Generic | Generic |
| Proprietary Name | Erlotinib |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Erlotinib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/1 |
| Substance Name | ERLOTINIB HYDROCHLORIDE |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA213065 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0913-06 (68382091306)
| NDC Package Code | 68382-913-06 |
|---|---|
| Billing NDC | 68382091306 |
| Package | 30 TABLET in 1 BOTTLE (68382-913-06) |
| Marketing Start Date | 2020-04-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |