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.
| Product ID | 68382-913_e715a711-283a-4662-8df0-d3b86ac5a042 |
| NDC | 68382-913 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Erlotinib |
| Generic Name | Erlotinib |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-04-30 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA213065 |
| Labeler Name | Zydus Pharmaceuticals (USA) Inc. |
| Substance Name | ERLOTINIB HYDROCHLORIDE |
| Active Ingredient Strength | 25 mg/1 |
| Pharm Classes | Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-04-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA213065 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-04-30 |
| Marketing Category | ANDA |
| Application Number | ANDA213065 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-04-30 |
| Marketing Category | ANDA |
| Application Number | ANDA213065 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-04-30 |
| Marketing Category | ANDA |
| Application Number | ANDA213065 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-04-30 |
| Ingredient | Strength |
|---|---|
| ERLOTINIB HYDROCHLORIDE | 25 mg/1 |
| SPL SET ID: | c35e019d-ec34-4e61-9400-a7ae7913e025 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-7662 | Erlotinib | Erlotinib |
| 0093-7663 | Erlotinib | Erlotinib |
| 0093-7664 | Erlotinib | Erlotinib |
| 51991-890 | Erlotinib | Erlotinib Hydrochloride |
| 51991-891 | Erlotinib | Erlotinib Hydrochloride |
| 51991-892 | Erlotinib | Erlotinib Hydrochloride |
| 59651-530 | Erlotinib | Erlotinib |
| 59651-531 | Erlotinib | Erlotinib |
| 59651-532 | Erlotinib | Erlotinib |
| 59923-725 | Erlotinib | Erlotinib |
| 59923-726 | Erlotinib | Erlotinib |
| 59923-727 | Erlotinib | Erlotinib |
| 63304-095 | Erlotinib | Erlotinib |
| 63304-096 | Erlotinib | Erlotinib |
| 63304-135 | Erlotinib | Erlotinib |
| 68382-913 | Erlotinib | Erlotinib |
| 68382-914 | Erlotinib | Erlotinib |
| 68382-915 | Erlotinib | Erlotinib |
| 70771-1521 | Erlotinib | Erlotinib |
| 70771-1522 | Erlotinib | Erlotinib |
| 70771-1523 | Erlotinib | Erlotinib |
| 72485-217 | Erlotinib | Erlotinib hydrochloride |
| 72485-218 | Erlotinib | Erlotinib hydrochloride |
| 72485-219 | Erlotinib | Erlotinib hydrochloride |