NDC 0074-2625

Mavyret

Glecaprevir And Pibrentasvir

Mavyret is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Abbvie Inc.. The primary component is Pibrentasvir; Glecaprevir.

• Product ID: 0074-2625_0e23f7a3-4101-5c43-1c00-79bf2d875952
• NDC: 0074-2625
• Product Type: Human Prescription Drug
• Proprietary Name: Mavyret
• Generic Name: Glecaprevir And Pibrentasvir
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-08-03
• Marketing Category: NDA / NDA
• Application Number: NDA209394
• Labeler Name: AbbVie Inc.
• Substance Name: PIBRENTASVIR; GLECAPREVIR
• Active Ingredient Strength: 40 mg/1; mg/1
• Pharm Classes: Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],UGT1A1 Inhibitors [MoA],Hepatitis C Virus NS3/4A Protease Inhibitor [EPC],HCV NS3/4A Protease Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],UGT1A1 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0074-2625-01

1 DOSE PACK in 1 CARTON (0074-2625-01) > 3 TABLET, FILM COATED in 1 DOSE PACK

• Marketing Start Date: 2017-08-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0074-2625-28 [00074262528]

Mavyret TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209394
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-03

NDC 0074-2625-01 [00074262501]

Mavyret TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209394
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-03

NDC 0074-2625-56 [00074262556]

Mavyret TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209394
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-03

NDC 0074-2625-80 [00074262580]

Mavyret TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209394
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-27
• Marketing End Date: 2020-04-14

Drug Details

Active Ingredients

Ingredient	Strength
PIBRENTASVIR	40 mg/1

OpenFDA Data

• SPL SET ID: 7bf99777-0401-9095-8645-16c6e907fcc0
• Manufacturer:
  • AbbVie Inc.
• UNII:
  • 2WU922TK3L
  • K6BUU8J72P
• RxNorm Concept Unique ID - RxCUI:
  • 1940703
  • 1940709

Pharmacological Class

• Hepatitis C Virus NS5A Inhibitor [EPC]
• P-Glycoprotein Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]
• Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
• Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
• Cytochrome P450 3A Inhibitors [MoA]
• Cytochrome P450 1A2 Inhibitors [MoA]
• UGT1A1 Inhibitors [MoA]
• Hepatitis C Virus NS3/4A Protease Inhibitor [EPC]
• HCV NS3/4A Protease Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]
• Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
• Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
• Cytochrome P450 3A Inhibitors [MoA]
• Cytochrome P450 1A2 Inhibitors [MoA]
• UGT1A1 Inhibitors [MoA]

NDC Crossover Matching brand name "Mavyret" or generic name "Glecaprevir And Pibrentasvir"

NDC	Brand Name	Generic Name
0074-2600	Mavyret	Glecaprevir and Pibrentasvir
0074-2625	Mavyret	Glecaprevir and Pibrentasvir