Entacapone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sunshine Lake Pharma Co., Ltd.. The primary component is Entacapone.
| Product ID | 48792-7830_77c463d8-84d8-231c-e053-2a91aa0a9fe4 |
| NDC | 48792-7830 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Entacapone |
| Generic Name | Entacapone |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-10-10 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA206669 |
| Labeler Name | Sunshine Lake Pharma Co., Ltd. |
| Substance Name | ENTACAPONE |
| Active Ingredient Strength | 200 mg/1 |
| Pharm Classes | Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2018-10-10 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA206669 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-10-10 |
| Marketing Category | ANDA |
| Application Number | ANDA206669 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-10-10 |
| Ingredient | Strength |
|---|---|
| ENTACAPONE | 200 mg/1 |
| SPL SET ID: | 77c463d8-84d7-231c-e053-2a91aa0a9fe4 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-9080 | Entacapone | Entacapone |
| 0527-1830 | Entacapone | entacapone |
| 0615-8298 | Entacapone | Entacapone |
| 0781-5578 | Entacapone | Entacapone |
| 0904-6822 | Entacapone | Entacapone |
| 27241-049 | Entacapone | Entacapone |
| 33342-260 | Entacapone | Entacapone |
| 43353-996 | Entacapone | Entacapone |
| 46708-478 | ENTACAPONE | ENTACAPONE |
| 47335-007 | Entacapone | Entacapone |
| 48792-7830 | Entacapone | entacapone |
| 50268-295 | Entacapone | Entacapone |
| 51079-273 | Entacapone | Entacapone |
| 55648-290 | Entacapone | Entacapone |
| 55648-711 | Entacapone | Entacapone |
| 55648-781 | Entacapone | Entacapone |
| 60687-188 | Entacapone | Entacapone |
| 62332-478 | ENTACAPONE | ENTACAPONE |
| 64679-290 | Entacapone | Entacapone |
| 64679-711 | Entacapone | Entacapone |
| 64679-781 | Entacapone | Entacapone |
| 71610-247 | Entacapone | Entacapone |
| 65862-654 | Entacapone | Entacapone |
| 0078-0327 | Comtan | entacapone |
| 52427-800 | Comtan | entacapone |