NDC 0006-3074
ZEPATIER
Elbasvir And Grazoprevir
ZEPATIER is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Elbasvir; Grazoprevir Anhydrous.
| Product ID | 0006-3074_1496b16e-fbbf-46e5-b2e8-e983026663be |
| NDC | 0006-3074 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ZEPATIER |
| Generic Name | Elbasvir And Grazoprevir |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2016-01-28 |
| Marketing Category | NDA / NDA |
| Application Number | NDA208261 |
| Labeler Name | Merck Sharp & Dohme Corp. |
| Substance Name | ELBASVIR; GRAZOPREVIR ANHYDROUS |
| Active Ingredient Strength | 50 mg/1; mg/1 |
| Pharm Classes | Hepatitis C Virus NS5A Inhibitor [EPC],Breast Cancer Resistance Protein Inhibitors [MoA],HCV NS3/4A Protease Inhibitors [MoA],Hepatitis C Virus NS3/4A Protease Inhibitor [EPC],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 0006-3074-02
2 DOSE PACK in 1 CARTON (0006-3074-02) > 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01)
| Marketing Start Date | 2016-01-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0006-3074-02 [00006307402]
ZEPATIER TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA208261 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-01-28 |
NDC 0006-3074-01 [00006307401]
ZEPATIER TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA208261 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-01-28 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ELBASVIR | 50 mg/1 |
OpenFDA Data
| SPL SET ID: | 164dc02a-9180-426a-b8b5-04ab39d2bbd4 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Hepatitis C Virus NS5A Inhibitor [EPC]
- Breast Cancer Resistance Protein Inhibitors [MoA]
- HCV NS3/4A Protease Inhibitors [MoA]
- Hepatitis C Virus NS3/4A Protease Inhibitor [EPC]
- Breast Cancer Resistance Protein Inhibitors [MoA]
- Cytochrome P450 3A Inhibitors [MoA]
Trademark Results [ZEPATIER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZEPATIER 86336186 4937479 Live/Registered |
Merck Sharp & Dohme Corp. 2014-07-14 |
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