Prescription drug · NDA
Zepatier (Elbasvir and grazoprevir) NDC 0006-3074
Elbasvir 50 mg/1; Grazoprevir anhydrous 100 mg/1 · Tablet, Film coated · Oral · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-3074-02 | 00006307402 | 2 DOSE PACK in 1 CARTON (0006-3074-02) / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01)Marketed from Jan 28, 2016 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Zepatier
- Generic name (nonproprietary)
- elbasvir and grazoprevir
- Active ingredients
- Elbasvir — 50 mg/1Grazoprevir anhydrous — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Merck Sharp & Dohme LLCNDC labeler code 0006
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208261
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)HCV NS3/4A Protease Inhibitors (Mechanism)
- Identifiers
- Product ID 0006-3074_227ae348-5f6f-44d8-a6dc-103e63d28102SPL ID 227ae348-5f6f-44d8-a6dc-103e63d28102SPL set ID 164dc02a-9180-426a-b8b5-04ab39d2bbd4RxCUI 1734636, 1734642UNII 632L571YDK, 8YE81R1X1J
- Pharmacologic class
- Hepatitis C Virus NS3/4A Protease Inhibitor; Hepatitis C Virus NS5A Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400006307402followed by a unit qualifier and the quantityPackage 00006-3074-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
ZEPATIER ® is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations [see Dosage and Administration (2.2) ] . ZEPATIER is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated for treatment of chronic HCV genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations. …
Excerpt only. Read the full label for complete information.
About NDC 0006-3074
- What is NDC 0006-3074?
- 0006-3074 is the product NDC for Zepatier, Elbasvir 50 mg/1; Grazoprevir anhydrous 100 mg/1 tablet, film coated, listed with the FDA by Merck Sharp & Dohme LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zepatier (Elbasvir and grazoprevir).
- What is the active ingredient?
- Elbasvir, Grazoprevir anhydrous.
- Who is the labeler?
- Merck Sharp & Dohme LLC, NDC labeler code 0006. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zepatier?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.