FDA.reportPublic FDA data

Mavyret

Product NDC
0074-2600
11-digit product format
000742600
Labeler code
0074
Product ID
0074-2600_2c392930-500d-4e9b-93ac-317c4d48251c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glecaprevir and Pibrentasvir
Dosage form
PELLET
Route
ORAL
Labeler
AbbVie Inc.
Application
NDA215110
Marketing category
NDA
Marketing start
2021-06-10
Substance
GLECAPREVIR; PIBRENTASVIR
Active strength
50; 20 mg/1; mg/1
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mavyret
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLECAPREVIR50 mg/1
PIBRENTASVIR20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK6BUU8J72P, 2WU922TK3L
Rxcui1940703, 1940709, 2557906, 2557910

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
524f6552-375e-4c3a-9cb4-a05b5c618216Product name120170830
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-2600-28Mavyret28 in 1 PACKETPELLET28200
0074-2600-28Mavyret1 in 1 CARTONPELLET1200

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-2600-28EA - Each0074-2600b2072f1b-db73-4eb9-bfd5-b384d155111212021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-2600MAVYRET (GLECAPREVIR AND PIBRENTASVIR) TABLET, FILM COATED MAVYRET (GLECAPREVIR AND PIBRENTASVIR) PELLET [ABBVIE INC.]197Current NDC, Legacy NDC, 2 package rows20250425_7bf99777-0401-9095-8645-16c6e907fcc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1940703glecaprevir 100 MG / pibrentasvir 40 MG Oral TabletPSN7bf99777-0401-9095-8645-16c6e907fcc0200
2557906glecaprevir 50 MG / pibrentasvir 20 MG per packet Oral PelletPSN7bf99777-0401-9095-8645-16c6e907fcc0200
1940709Mavyret 100 MG / 40 MG Oral TabletPSN7bf99777-0401-9095-8645-16c6e907fcc0200
2557910Mavyret 50 MG / 20 MG per packet Oral PelletPSN7bf99777-0401-9095-8645-16c6e907fcc0200
1940709glecaprevir 100 MG / pibrentasvir 40 MG Oral Tablet [Mavyret]SBD7bf99777-0401-9095-8645-16c6e907fcc0200
2557910glecaprevir 50 MG / pibrentasvir 20 MG Oral Pellet [Mavyret]SBD7bf99777-0401-9095-8645-16c6e907fcc0200
1940703glecaprevir 100 MG / pibrentasvir 40 MG Oral TabletSCD7bf99777-0401-9095-8645-16c6e907fcc0200
2557906glecaprevir 50 MG / pibrentasvir 20 MG Oral PelletSCD7bf99777-0401-9095-8645-16c6e907fcc0200
1940709Mavyret (glecaprevir 100 MG / pibrentasvir 40 MG) Oral TabletSY7bf99777-0401-9095-8645-16c6e907fcc0200
2557910Mavyret (glecaprevir 50 MG / pibrentasvir 20 MG) per packet Oral PelletSY7bf99777-0401-9095-8645-16c6e907fcc0200

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-2600-28000742600281 PACKET in 1 CARTON (0074-2600-28) / 28 PELLET in 1 PACKET1 packet2021-06-220000-00-00NoNoCurrent
0074-2600-60000742600601 PACKET in 1 CARTON (0074-2600-60) > 60 PELLET in 1 PACKET1 packet2021-06-100000-00-00NoNoCurrent