Entecavir is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals Usa Inc.. The primary component is Entecavir.
| Product ID | 68382-920_4d1797fc-b21a-4dbe-8a35-2acbbcf741a1 |
| NDC | 68382-920 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Entecavir |
| Generic Name | Entecavir |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-08-10 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA206745 |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Substance Name | ENTECAVIR |
| Active Ingredient Strength | 1 mg/1 |
| Pharm Classes | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2017-08-10 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA206745 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-08-10 |
| Marketing Category | ANDA |
| Application Number | ANDA206745 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-08-10 |
| Marketing Category | ANDA |
| Application Number | ANDA206745 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-08-10 |
| Marketing Category | ANDA |
| Application Number | ANDA206745 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-08-10 |
| Marketing Category | ANDA |
| Application Number | ANDA206745 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-08-10 |
| Ingredient | Strength |
|---|---|
| ENTECAVIR | .5 mg/1 |
| SPL SET ID: | b4fd0e22-ad23-4f51-9b98-95182f63c2eb |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-5786 | Entecavir | Entecavir |
| 0093-5787 | Entecavir | Entecavir |
| 10135-615 | Entecavir | Entecavir |
| 10135-616 | Entecavir | Entecavir |
| 16714-717 | ENTECAVIR | ENTECAVIR |
| 16714-718 | ENTECAVIR | ENTECAVIR |
| 16729-388 | Entecavir | Entecavir |
| 16729-389 | Entecavir | Entecavir |
| 31722-833 | Entecavir | Entecavir |
| 31722-834 | Entecavir | Entecavir |
| 42291-261 | Entecavir | Entecavir |
| 42291-262 | Entecavir | Entecavir |
| 68382-920 | Entecavir | Entecavir |
| 68382-921 | Entecavir | Entecavir |
| 69097-425 | ENTECAVIR | ENTECAVIR |
| 69097-426 | ENTECAVIR | ENTECAVIR |
| 70771-1019 | Entecavir | Entecavir |
| 70771-1020 | Entecavir | Entecavir |
| 43547-437 | ENTECAVIR | ENTECAVIR |
| 43547-436 | ENTECAVIR | ENTECAVIR |
| 49884-547 | Entecavir | Entecavir |
| 49884-548 | Entecavir | Entecavir |
| 51407-065 | Entecavir | Entecavir |
| 51407-064 | Entecavir | Entecavir |
| 52343-147 | ENTECAVIR | ENTECAVIR |
| 51991-896 | Entecavir | Entecavir |
| 51991-895 | Entecavir | Entecavir |
| 52343-148 | ENTECAVIR | ENTECAVIR |
| 60687-216 | Entecavir | Entecavir |
| 65162-446 | Entecavir | Entecavir |
| 65862-842 | Entecavir | Entecavir |
| 65162-449 | Entecavir | Entecavir |
| 65862-841 | Entecavir | Entecavir |
| 62227-102 | Entecavir | Entecavir |
| 62227-101 | Entecavir | Entecavir |
| 0003-1611 | BARACLUDE | entecavir |
| 0003-1612 | BARACLUDE | entecavir |
| 0003-1614 | BARACLUDE | entecavir |