Mavyret

Product NDC: 0074-2625
Requested package NDC: 0074-2625-01
11-digit product format: 000742625
Labeler code: 0074
Product ID: 0074-2625_2c392930-500d-4e9b-93ac-317c4d48251c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glecaprevir and Pibrentasvir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AbbVie Inc.
Application: NDA209394
Marketing category: NDA
Marketing start: 2017-08-03
Substance: GLECAPREVIR; PIBRENTASVIR
Active strength: 100; 40 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0074-2625	0074-2625-01	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0074-2625	0074-2625-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0074-2625	0074-2625-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N209394-001	MAVYRET	GLECAPREVIR; PIBRENTASVIR	100MG;40MG	TABLET / ORAL		RLD, RS	2017-08-03

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209394-001	10028937	2030-06-10	U-2141		2018-08-24
N209394-001	10028937	2030-06-10	U-3237		2018-08-24
N209394-001	10028937	2030-06-10	U-4206		2018-08-24
N209394-001	10039754	2030-06-10	U-2141		2018-09-06
N209394-001	10039754	2030-06-10	U-3237		2018-09-06
N209394-001	10039754	2030-06-10	U-4206		2018-09-06
N209394-001	9586978	2030-11-06	U-2141		2017-08-29
N209394-001	9586978	2030-11-06	U-3237		2017-08-29
N209394-001	9586978	2030-11-06	U-4206		2017-08-29
N209394-001	10028937*PED	2030-12-10		Pediatric extension
N209394-001	10039754*PED	2030-12-10		Pediatric extension
N209394-001	9586978*PED	2031-05-06		Pediatric extension
N209394-001	8648037	2032-01-19	U-2141	Drug substance, Drug product	2017-08-29
N209394-001	8648037	2032-01-19	U-3237	Drug substance, Drug product	2017-08-29
N209394-001	8648037	2032-01-19	U-4206	Drug substance, Drug product	2017-08-29
N209394-001	8937150	2032-05-18		Drug substance, Drug product	2017-08-29
N209394-001	8648037*PED	2032-07-19		Pediatric extension
N209394-001	8937150*PED	2032-11-18		Pediatric extension
N209394-001	10286029	2034-03-14	U-3237		2019-05-31
N209394-001	10286029	2034-03-14	U-4206		2019-05-31
N209394-001	11484534	2034-03-14	U-3237		2022-11-30
N209394-001	11484534	2034-03-14	U-4206		2022-11-30
N209394-001	10286029*PED	2034-09-14		Pediatric extension
N209394-001	11484534*PED	2034-09-14		Pediatric extension
N209394-001	RE48923	2035-05-08		Drug substance	2022-03-08
N209394-001	9321807	2035-06-05		Drug substance	2017-08-29
N209394-001	RE48923*PED	2035-11-08		Pediatric extension
N209394-001	9321807*PED	2035-12-05		Pediatric extension
N209394-001	11246866	2036-06-24		Drug product	2022-03-08
N209394-001	11246866*PED	2036-12-24		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 7 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209394-001	ODE-232	2026-04-30
N209394-001	ODE-233	2026-04-30
N209394-001	PED	2026-10-30
N209394-001	PED	2026-10-30
N209394-001	I-967	2028-06-10
N209394-001	ODE-372	2028-06-10
N209394-001	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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209394-001	MAVYRET	100MG;40MG	TABLET / ORAL	RLD, RS	2017-08-03	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 22 · 879 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209394-001	10028937	2030-06-10	U-4206		2018-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	10028937	2030-06-10	U-2141		2018-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	10028937	2030-06-10	U-3237		2018-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	10039754	2030-06-10	U-2141		2018-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	10039754	2030-06-10	U-4206		2018-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	10039754	2030-06-10	U-3237		2018-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	9586978	2030-11-06	U-4206		2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	9586978	2030-11-06	U-3237		2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	9586978	2030-11-06	U-2141		2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	10028937*PED	2030-12-10		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	10039754*PED	2030-12-10		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	9586978*PED	2031-05-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	8648037	2032-01-19	U-2141	Drug substance, Drug product	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	8648037	2032-01-19	U-4206	Drug substance, Drug product	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	8648037	2032-01-19	U-3237	Drug substance, Drug product	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	8937150	2032-05-18		Drug substance, Drug product	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	8648037*PED	2032-07-19		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	8937150*PED	2032-11-18		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	10286029	2034-03-14	U-4206		2019-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	10286029	2034-03-14	U-3237		2019-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	11484534	2034-03-14	U-4206		2022-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	11484534	2034-03-14	U-3237		2022-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	10286029*PED	2034-09-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	11484534*PED	2034-09-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	RE48923	2035-05-08		Drug substance	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	9321807	2035-06-05		Drug substance	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	RE48923*PED	2035-11-08		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	9321807*PED	2035-12-05		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	11246866	2036-06-24		Drug product	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	11246866*PED	2036-12-24		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	10028937	2030-06-10	U-4206		2018-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	10028937	2030-06-10	U-2141		2018-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	10028937	2030-06-10	U-3237		2018-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	10039754	2030-06-10	U-2141		2018-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	10039754	2030-06-10	U-4206		2018-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	10039754	2030-06-10	U-3237		2018-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	9586978	2030-11-06	U-4206		2017-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	9586978	2030-11-06	U-3237		2017-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	9586978	2030-11-06	U-2141		2017-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	10028937*PED	2030-12-10		Pediatric extension		`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 9 · 355 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209394-001	ODE-232	2026-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	ODE-233	2026-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	PED	2026-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	PED	2026-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	I-967	2028-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	ODE-372	2028-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209394-001	PED	2028-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	ODE-232	2026-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	ODE-233	2026-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	PED	2026-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	PED	2026-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	I-967	2028-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	ODE-372	2028-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209394-001	PED	2028-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209394-001	ODE-232	2026-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209394-001	ODE-233	2026-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209394-001	PED	2026-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209394-001	PED	2026-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209394-001	I-967	2028-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209394-001	ODE-372	2028-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209394-001	PED	2028-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209394-001	ODE-232	2026-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209394-001	ODE-233	2026-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209394-001	PED	2026-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209394-001	PED	2026-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209394-001	ODE-372	2028-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209394-001	PED	2028-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209394-001	ODE-232	2026-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209394-001	ODE-233	2026-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209394-001	PED	2026-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209394-001	PED	2026-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209394-001	ODE-372	2028-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209394-001	PED	2028-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209394-001	ODE-232	2026-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209394-001	ODE-233	2026-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209394-001	PED	2026-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209394-001	PED	2026-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209394-001	ODE-372	2028-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209394-001	PED	2028-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209394-001	ODE-232	2026-04-30	`2680178bc6a6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PIBRENTASVIR	100 mg/1
GLECAPREVIR	40 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7bf99777-0401-9095-8645-16c6e907fcc0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
524f6552-375e-4c3a-9cb4-a05b5c618216	Product name	1	20170830
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0074-2625-01	Mavyret	1 in 1 CARTON	TABLET, FILM COATED	1	200
0074-2625-01	Mavyret	3 in 1 DOSE PACK	TABLET, FILM COATED	3	200
0074-2625-04	Mavyret	4 in 1 CARTON	TABLET, FILM COATED	4	200
0074-2625-04	Mavyret	7 in 1 CARTON	TABLET, FILM COATED	7	200
0074-2625-28	Mavyret	7 in 1 CARTON	TABLET, FILM COATED	7	200
0074-2625-28	Mavyret	4 in 1 CARTON	TABLET, FILM COATED	4	200
0074-2625-56	Mavyret	4 in 1 CARTON	TABLET, FILM COATED	4	200
0074-2625-56	Mavyret	2 in 1 CARTON	TABLET, FILM COATED	2	200
0074-2625-80	Mavyret	84 in 1 BOTTLE	TABLET, FILM COATED	84	200
0074-2625-84	Mavyret	84 in 1 BOTTLE	TABLET, FILM COATED	84	200

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0074-2625-04	EA - Each	0074-2625	e2cd229e-67db-4f1e-a8c2-963f548dd76b	1	2025-09-12
0074-2625-28	EA - Each	0074-2625	e435e09b-79e4-4670-a302-96acfec1c332	1	2017-09-11
0074-2625-80	EA - Each	0074-2625	1c8b7ac4-c2f5-424d-9127-51c673c8d0cd	1	2019-09-05
0074-2625-84	EA - Each	0074-2625	5d0afa2c-f58c-475c-b5c5-24e1a8872d21	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0074-2625	MAVYRET (GLECAPREVIR AND PIBRENTASVIR) TABLET, FILM COATED MAVYRET (GLECAPREVIR AND PIBRENTASVIR) PELLET [ABBVIE INC.]	197	Current NDC, Legacy NDC, 10 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	2025-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209394 application number: NDA209394 ndc (package): 0074-2625-01 ndc (product): 0074-2625 ndc11 (package): 00074262501

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K6BUU8J72P	GLECAPREVIR	1365970-03-1	GLECAPREVIR
2WU922TK3L	PIBRENTASVIR	1353900-92-1	PIBRENTASVIR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1940703	glecaprevir 100 MG / pibrentasvir 40 MG Oral Tablet	PSN	7bf99777-0401-9095-8645-16c6e907fcc0	200
2557906	glecaprevir 50 MG / pibrentasvir 20 MG per packet Oral Pellet	PSN	7bf99777-0401-9095-8645-16c6e907fcc0	200
1940709	Mavyret 100 MG / 40 MG Oral Tablet	PSN	7bf99777-0401-9095-8645-16c6e907fcc0	200
2557910	Mavyret 50 MG / 20 MG per packet Oral Pellet	PSN	7bf99777-0401-9095-8645-16c6e907fcc0	200
1940709	glecaprevir 100 MG / pibrentasvir 40 MG Oral Tablet [Mavyret]	SBD	7bf99777-0401-9095-8645-16c6e907fcc0	200
2557910	glecaprevir 50 MG / pibrentasvir 20 MG Oral Pellet [Mavyret]	SBD	7bf99777-0401-9095-8645-16c6e907fcc0	200
1940703	glecaprevir 100 MG / pibrentasvir 40 MG Oral Tablet	SCD	7bf99777-0401-9095-8645-16c6e907fcc0	200
2557906	glecaprevir 50 MG / pibrentasvir 20 MG Oral Pellet	SCD	7bf99777-0401-9095-8645-16c6e907fcc0	200
1940709	Mavyret (glecaprevir 100 MG / pibrentasvir 40 MG) Oral Tablet	SY	7bf99777-0401-9095-8645-16c6e907fcc0	200
2557910	Mavyret (glecaprevir 50 MG / pibrentasvir 20 MG) per packet Oral Pellet	SY	7bf99777-0401-9095-8645-16c6e907fcc0	200

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0074-2625-01	00074262501	1 DOSE PACK in 1 CARTON (0074-2625-01) > 3 TABLET, FILM COATED in 1 DOSE PACK	1 dose pack	2017-08-03	0000-00-00	No	No	Current