Home NDC 0074-2600 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215110-001 MAVYRET GLECAPREVIR; PIBRENTASVIR 50MG/PACKET;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10
Orange Book patents# Current patent rows page 1 of 1 · 21 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215110-001 10028937 2030-06-10 U-3238 2021-07-08 N215110-001 10028937 2030-06-10 U-4206 2021-07-08 N215110-001 10039754 2030-06-10 U-3238 2021-07-08 N215110-001 10039754 2030-06-10 U-4206 2021-07-08 N215110-001 9586978 2030-11-06 U-3238 2021-07-08 N215110-001 9586978 2030-11-06 U-4206 2021-07-08 N215110-001 10028937*PED 2030-12-10 Pediatric extension N215110-001 10039754*PED 2030-12-10 Pediatric extension N215110-001 9586978*PED 2031-05-06 Pediatric extension N215110-001 8648037 2032-01-19 U-3238 Drug substance, Drug product 2021-07-08 N215110-001 8648037 2032-01-19 U-4206 Drug substance, Drug product 2021-07-08 N215110-001 8937150 2032-05-18 Drug substance, Drug product 2021-07-08 N215110-001 8648037*PED 2032-07-19 Pediatric extension N215110-001 8937150*PED 2032-11-18 Pediatric extension N215110-001 10286029 2034-03-14 U-3238 2021-07-08 N215110-001 10286029 2034-03-14 U-4206 2021-07-08 N215110-001 10286029*PED 2034-09-14 Pediatric extension N215110-001 RE48923 2035-05-08 Drug substance 2022-03-08 N215110-001 9321807 2035-06-05 Drug substance, Drug product 2021-07-08 N215110-001 RE48923*PED 2035-11-08 Pediatric extension N215110-001 9321807*PED 2035-12-05 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215110-001 I-967 2028-06-10 N215110-001 ODE-372 2028-06-10 N215110-001 PED 2028-12-10
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N215110-001 MAVYRET 50MG/PACKET;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215110-001 MAVYRET 50MG;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215110-001 MAVYRET 50MG/PACKET;20MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 15 · 566 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N215110-001 10028937 2030-06-10 U-4206 2021-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 10028937 2030-06-10 U-3238 2021-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 10039754 2030-06-10 U-4206 2021-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 10039754 2030-06-10 U-3238 2021-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 9586978 2030-11-06 U-4206 2021-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 9586978 2030-11-06 U-3238 2021-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 10028937*PED 2030-12-10 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 10039754*PED 2030-12-10 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 9586978*PED 2031-05-06 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 8648037 2032-01-19 U-4206 Drug substance, Drug product 2021-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 8648037 2032-01-19 U-3238 Drug substance, Drug product 2021-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 8937150 2032-05-18 Drug substance, Drug product 2021-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 8648037*PED 2032-07-19 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 8937150*PED 2032-11-18 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 10286029 2034-03-14 U-4206 2021-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 10286029 2034-03-14 U-3238 2021-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 10286029*PED 2034-09-14 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 RE48923 2035-05-08 Drug substance 2022-03-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 9321807 2035-06-05 Drug substance, Drug product 2021-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 RE48923*PED 2035-11-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215110-001 9321807*PED 2035-12-05 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215110-001 10028937 2030-06-10 U-4206 2021-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 10028937 2030-06-10 U-3238 2021-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 10039754 2030-06-10 U-4206 2021-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 10039754 2030-06-10 U-3238 2021-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 9586978 2030-11-06 U-4206 2021-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 9586978 2030-11-06 U-3238 2021-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 10028937*PED 2030-12-10 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 10039754*PED 2030-12-10 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 9586978*PED 2031-05-06 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 8648037 2032-01-19 U-4206 Drug substance, Drug product 2021-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 8648037 2032-01-19 U-3238 Drug substance, Drug product 2021-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 8937150 2032-05-18 Drug substance, Drug product 2021-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 8648037*PED 2032-07-19 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 8937150*PED 2032-11-18 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 10286029 2034-03-14 U-4206 2021-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 10286029 2034-03-14 U-3238 2021-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 10286029*PED 2034-09-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 RE48923 2035-05-08 Drug substance 2022-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215110-001 9321807 2035-06-05 Drug substance, Drug product 2021-07-08 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 155 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Mavyret
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIBRENTASVIR 50 mg/1 GLECAPREVIR 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2WU922TK3L Internal UNII lookup K6BUU8J72P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1940703 Internal RxNorm lookup 1940709 Internal RxNorm lookup 2557906 Internal RxNorm lookup 2557910 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0074-2600-28 Mavyret 28 in 1 PACKET PELLET 28 200 0074-2600-28 Mavyret 1 in 1 CARTON PELLET 1 200
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0074-2600 MAVYRET (GLECAPREVIR AND PIBRENTASVIR) TABLET, FILM COATED MAVYRET (GLECAPREVIR AND PIBRENTASVIR) PELLET [ABBVIE INC.] 197 Current NDC, Legacy NDC, 2 package rows 20250425_7bf99777-0401-9095-8645-16c6e907fcc0.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mavyret GLECAPREVIR AND PIBRENTASVIR AbbVie Inc. 7bf99777-0401-9095-8645-16c6e907fcc0 2025-06-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 215110 application number: NDA215110 ndc (product): 0074-2600
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0074-2600-28 00074260028 1 PACKET in 1 CARTON (0074-2600-28) / 28 PELLET in 1 PACKET 1 packet 2021-06-22 0000-00-00 No No Current 0074-2600-60 00074260060 1 PACKET in 1 CARTON (0074-2600-60) > 60 PELLET in 1 PACKET 1 packet 2021-06-10 0000-00-00 No No Current