| Product NDC: | 54868-5290 |
| Proprietary Name: | Tarceva |
| Non Proprietary Name: | erlotinib hydrochloride |
| Active Ingredient(s): | 25 mg/1 & nbsp; erlotinib hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 54868-5290 |
| Labeler Name: | Physicians Total Care, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021743 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20050701 |
| Package NDC: | 54868-5290-0 |
| Package Description: | 30 TABLET in 1 BOTTLE (54868-5290-0) |
| NDC Code | 54868-5290-0 |
| Proprietary Name | Tarceva |
| Package Description | 30 TABLET in 1 BOTTLE (54868-5290-0) |
| Product NDC | 54868-5290 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | erlotinib hydrochloride |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20050701 |
| Marketing Category Name | NDA |
| Labeler Name | Physicians Total Care, Inc. |
| Substance Name | ERLOTINIB HYDROCHLORIDE |
| Strength Number | 25 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] |