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MAVYRE(glecaprevir and pibrentasvir)tablets(二十四)
2018-03-26 04:31:24 来源: 作者: 【 】 浏览:12045次 评论:0
weekly wallet
NDC 0074-2625-01
Rx only
Mavyret™
(glecaprevir and pibrentasvir)
100mg/40mg
Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg
Please see accompanying full Prescribing Information
Each box contains: 1 wallet of 3 tablets each
Keep out of reach of children
Store at or below 30°C (86°F)
See Package Insert for full Prescribing Information
AbbVie Inc.
North Chicago, IL 60064
Product of Ireland
©2017 AbbVie Inc.
replacement pack
INGREDIENTS AND APPEARANCE
MAVYRET
glecaprevir and pibrentasvir tablet, film coated
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-2625
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
PIBRENTASVIR (UNII: 2WU922TK3L) (PIBRENTASVIR - UNII:2WU922TK3L) PIBRENTASVIR 40 mg
GLECAPREVIR (UNII: K6BUU8J72P) (GLECAPREVIR - UNII:K6BUU8J72P) GLECAPREVIR 100 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
COPOVIDONE (UNII: D9C330MD8B) 
TOCOPHERSOLAN (UNII: O03S90U1F2) 
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 
PROPYLENE GLYCOL CAPRYLATE (UNII: RT9P9S09QI) 
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) 
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) 
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) 
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 
FERRIC OXIDE RED (UNII: 1K09F3G675) 
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 
PRODUCT CHARACTERISTICS
Color PINK Score no score
Shape OVAL (oblong biconvex) Size 19mm
Flavor  Imprint Code NXT
Contains    
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0074-2625-28 4 in 1 CARTON 08/03/2017 
1  7 in 1 CARTON  
1  3 in 1 DOSE PACK; Type 0: Not a Combination Product  
2 NDC:0074-2625-56 2 in 1 CARTON 08/03/2017 
2  4 in 1 CARTON  
2  7 in 1 CARTON  
2  3 in 1 DOSE PACK; Type 0: Not a Combination Product  
3 NDC:0074-2625-01 1 in 1 CARTON 08/03/2017 
3  3 in 1 DOSE PACK; Type 0: Not a Combination Product  
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209394 08/03/2017
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7bf99777-0401-9095-8645-16c6e907fcc0 
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