mavyret

Generic: glecaprevir and pibrentasvir

Labeler: abbvie inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mavyret
Generic Name glecaprevir and pibrentasvir
Labeler abbvie inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

glecaprevir 100 mg/1, pibrentasvir 40 mg/1

Manufacturer
AbbVie Inc.

Identifiers & Regulatory

Product NDC 0074-2625
Product ID 0074-2625_2c392930-500d-4e9b-93ac-317c4d48251c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209394
Listing Expiration 2027-12-31
Marketing Start 2017-08-03

Pharmacologic Class

Established (EPC)
hepatitis c virus ns3/4a protease inhibitor [epc] hepatitis c virus ns5a inhibitor [epc]
Mechanism of Action
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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00742625
Hyphenated Format 0074-2625

Supplemental Identifiers

RxCUI
1940703 1940709 2557906 2557910
UNII
K6BUU8J72P 2WU922TK3L
NUI
N0000182639 N0000182638 N0000185503 N0000190113 N0000190107 N0000190108 N0000190114 N0000182138 N0000191272 N0000191256

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mavyret (source: ndc)
Generic Name glecaprevir and pibrentasvir (source: ndc)
Application Number NDA209394 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 4 CARTON in 1 CARTON (0074-2625-04) / 7 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK
  • 4 CARTON in 1 CARTON (0074-2625-28) / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK
  • 2 CARTON in 1 CARTON (0074-2625-56) / 4 CARTON in 1 CARTON / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK
  • 84 TABLET, FILM COATED in 1 BOTTLE (0074-2625-84)
source: ndc

Packages (4)

0074-2625-04 4 CARTON in 1 CARTON (0074-2625-04) / 7 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK 0074-2625-28 4 CARTON in 1 CARTON (0074-2625-28) / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK 0074-2625-56 2 CARTON in 1 CARTON (0074-2625-56) / 4 CARTON in 1 CARTON / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK 0074-2625-84 84 TABLET, FILM COATED in 1 BOTTLE (0074-2625-84)

Ingredients (2)

glecaprevir (100 mg/1) pibrentasvir (40 mg/1)

Linked Drug Pages (1)

Mavyret ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c392930-500d-4e9b-93ac-317c4d48251c", "openfda": {"nui": ["N0000182639", "N0000182638", "N0000185503", "N0000190113", "N0000190107", "N0000190108", "N0000190114", "N0000182138", "N0000191272", "N0000191256"], "unii": ["K6BUU8J72P", "2WU922TK3L"], "rxcui": ["1940703", "1940709", "2557906", "2557910"], "spl_set_id": ["7bf99777-0401-9095-8645-16c6e907fcc0"], "pharm_class_epc": ["Hepatitis C Virus NS3/4A Protease Inhibitor [EPC]", "Hepatitis C Virus NS5A Inhibitor [EPC]"], "pharm_class_moa": ["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]"], "manufacturer_name": ["AbbVie Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 CARTON in 1 CARTON (0074-2625-04)  / 7 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0074-2625-04", "marketing_start_date": "20250415"}, {"sample": false, "description": "4 CARTON in 1 CARTON (0074-2625-28)  / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK", "package_ndc": "0074-2625-28", "marketing_start_date": "20170803"}, {"sample": false, "description": "2 CARTON in 1 CARTON (0074-2625-56)  / 4 CARTON in 1 CARTON / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK", "package_ndc": "0074-2625-56", "marketing_start_date": "20170803"}, {"sample": false, "description": "84 TABLET, FILM COATED in 1 BOTTLE (0074-2625-84)", "package_ndc": "0074-2625-84", "marketing_start_date": "20210622"}], "brand_name": "Mavyret", "product_id": "0074-2625_2c392930-500d-4e9b-93ac-317c4d48251c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "HCV NS3/4A Protease Inhibitors [MoA]", "Hepatitis C Virus NS3/4A Protease Inhibitor [EPC]", "Hepatitis C Virus NS5A Inhibitor [EPC]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "UGT1A1 Inhibitors [MoA]", "UGT1A1 Inhibitors [MoA]"], "product_ndc": "0074-2625", "generic_name": "Glecaprevir and Pibrentasvir", "labeler_name": "AbbVie Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mavyret", "active_ingredients": [{"name": "GLECAPREVIR", "strength": "100 mg/1"}, {"name": "PIBRENTASVIR", "strength": "40 mg/1"}], "application_number": "NDA209394", "marketing_category": "NDA", "marketing_start_date": "20170803", "listing_expiration_date": "20271231"}