Mavyret
These highlights do not include all the information needed to use MAVYRET safely and effectively. See full prescribing information for MAVYRET. MAVYRET (glecaprevir and pibr entasvir) tablets, for oral use MAVYRET (glecaprevir and pibrentasvir) oral pellets Initial U.S. Approval: 2017
Approved
Approval ID
7bf99777-0401-9095-8645-16c6e907fcc0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2023
Manufacturers
FDA
AbbVie Inc.
DUNS: 078458370
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glecaprevir and Pibrentasvir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0074-2600
Application NumberNDA215110
Product Classification
M
Marketing Category
C73594
G
Generic Name
Glecaprevir and Pibrentasvir
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (14)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
PIBRENTASVIRActive
Quantity: 20 mg in 1 1
Code: 2WU922TK3L
Classification: ACTIB
GLECAPREVIRActive
Quantity: 50 mg in 1 1
Code: K6BUU8J72P
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PROPYLENE GLYCOL MONOCAPRYLATEInactive
Code: RT9P9S09QI
Classification: IACT
VITAMIN E POLYETHYLENE GLYCOL SUCCINATEInactive
Code: O03S90U1F2
Classification: IACT
Glecaprevir and Pibrentasvir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0074-2625
Application NumberNDA209394
Product Classification
M
Marketing Category
C73594
G
Generic Name
Glecaprevir and Pibrentasvir
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (13)
PIBRENTASVIRActive
Quantity: 40 mg in 1 1
Code: 2WU922TK3L
Classification: ACTIB
GLECAPREVIRActive
Quantity: 100 mg in 1 1
Code: K6BUU8J72P
Classification: ACTIB
VITAMIN E POLYETHYLENE GLYCOL SUCCINATEInactive
Code: O03S90U1F2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
PROPYLENE GLYCOL MONOCAPRYLATEInactive
Code: RT9P9S09QI
Classification: IACT