Prescription drug · NDA
Mavyret (Glecaprevir and pibrentasvir) NDC 0074-2600
Pibrentasvir 20 mg/1; Glecaprevir 50 mg/1 · Pellet · Oral · AbbVie Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0074-2600-28 | 00074260028 | 1 PACKET in 1 CARTON (0074-2600-28) / 28 PELLET in 1 PACKETMarketed from Jun 22, 2021 |
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)
- Mavyret
- Generic name (nonproprietary)
- glecaprevir and pibrentasvir
- Active ingredients
- Pibrentasvir — 20 mg/1Glecaprevir — 50 mg/1
- Dosage form
- Pellet
- Route
- Oral
- Labeler
- AbbVie Inc.NDC labeler code 0074
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215110
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 1A2 Inhibitors (Mechanism)Cytochrome P450 1A2 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)HCV NS3/4A Protease Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)UGT1A1 Inhibitors (Mechanism)UGT1A1 Inhibitors (Mechanism)
- Identifiers
- Product ID 0074-2600_c1aa97e0-7350-4286-ac17-915bcdf0b08aSPL ID c1aa97e0-7350-4286-ac17-915bcdf0b08aSPL set ID 7bf99777-0401-9095-8645-16c6e907fcc0RxCUI 1940703, 1940709, 2557906, 2557910UNII K6BUU8J72P, 2WU922TK3L
- 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
N400074260028followed by a unit qualifier and the quantityPackage 00074-2600-28. 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)
MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both [see Dosage and Administration ( 2.2 ) and Clinical Studies ( 14 )]. MAVYRET is a fixed-dose combination of glecaprevir, a hepatitis C virus (HCV) NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibit…
Excerpt only. Read the full label for complete information.
About NDC 0074-2600
- What is NDC 0074-2600?
- 0074-2600 is the product NDC for Mavyret, Pibrentasvir 20 mg/1; Glecaprevir 50 mg/1 pellet, listed with the FDA by AbbVie Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mavyret (Glecaprevir and Pibrentasvir).
- What is the active ingredient?
- Pibrentasvir, Glecaprevir.
- Who is the labeler?
- AbbVie Inc., NDC labeler code 0074. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mavyret?
- 1 other product NDC are listed under this name. See all Mavyret NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mavyret products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mavyretglecaprevir and pibrentasvir | Pibrentasvir 40 mg/1; Glecaprevir 100 mg/1 | Tablet, Film coatedOral | AbbVie Inc. | 0074-2625 | 00074-2625-0400074-2625-2800074-2625-56+1 more |