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 | 68382-914_e715a711-283a-4662-8df0-d3b86ac5a042 |
NDC | 68382-914 |
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 | 100 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 | 100 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 |