ZEPATIER

Product NDC: 0006-3074
11-digit product format: 000063074
Labeler code: 0006
Product ID: 0006-3074_227ae348-5f6f-44d8-a6dc-103e63d28102
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: elbasvir and grazoprevir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Merck Sharp & Dohme LLC
Application: NDA208261
Marketing category: NDA
Marketing start: 2016-01-28
Substance: ELBASVIR; GRAZOPREVIR ANHYDROUS
Active strength: 50; 100 mg/1; mg/1
Pharmacologic classes: Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein 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]
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
N208261-001	ZEPATIER	ELBASVIR; GRAZOPREVIR	50MG;100MG	TABLET / ORAL		RLD	2016-01-28

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25
N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD	2016-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD	2016-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208261-001	ZEPATIER	50MG;100MG	TABLET / ORAL	RLD, RS	2016-01-28	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 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	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208261-001	7973040	2029-07-24	U-1813	Drug substance, Drug product	2016-02-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208261-001	8871759	2031-05-04	U-1813	Drug substance, Drug product	2016-02-25	`bb7c543d1eb4…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208261-001	NPP	2024-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208261-001	NPP	2024-12-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208261-001	NPP	2024-12-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208261-001	NPP	2024-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208261-001	NPP	2024-12-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208261-001	NPP	2024-12-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208261-001	NPP	2024-12-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208261-001	NPP	2024-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208261-001	NPP	2024-12-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208261-001	NPP	2024-12-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208261-001	NPP	2024-12-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208261-001	NPP	2024-12-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208261-001	NCE	2021-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208261-001	NPP	2024-12-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208261-001	NCE	2021-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208261-001	NCE	2021-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208261-001	NCE	2021-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208261-001	NCE	2021-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208261-001	NCE	2021-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208261-001	NCE	2021-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208261-001	NCE	2021-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208261-001	NCE	2021-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208261-001	NPP	2024-12-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208261-001	NPP	2024-12-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208261-001	NPP	2024-12-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208261-001	NPP	2024-12-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208261-001	NPP	2024-12-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208261-001	NPP	2024-12-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208261-001	NPP	2024-12-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208261-001	NPP	2024-12-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208261-001	NPP	2024-12-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208261-001	NPP	2024-12-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208261-001	NPP	2024-12-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208261-001	NPP	2024-12-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208261-001	NPP	2024-12-09	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ELBASVIR	50 mg/1
GRAZOPREVIR ANHYDROUS	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
632L571YDK	Internal UNII lookup
8YE81R1X1J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1734636	Internal RxNorm lookup
1734642	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
164dc02a-9180-426a-b8b5-04ab39d2bbd4	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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
5f3efb1b-b5d2-4e4f-b00d-591593cf9cad	Product name	1	20160412
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0006-3074-02	2024-01-30	C162847	48780-1	1030e365-3199-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use ZEPATIER safely and effectively. See full prescribing information for ZEPATIER. ZEPATIER ® (elbasvir and grazoprevir) tablets, for oral use Initial U.S. Approval: 2016
0006-3074-02	2024-01-30	C162847	48780-1	1030e365-3199-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use ZEPATIER safely and effectively. See full prescribing information for ZEPATIER. ZEPATIER ® (elbasvir and grazoprevir) tablets, for oral use Initial U.S. Approval: 2016
0006-3074-02	2024-01-30	C162847	48780-1	1030e365-3199-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use ZEPATIER safely and effectively. See full prescribing information for ZEPATIER. ZEPATIER ® (elbasvir and grazoprevir) tablets, for oral use Initial U.S. Approval: 2016

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0006-3074-01	ZEPATIER	14 in 1 DOSE PACK	TABLET, FILM COATED	14		22
0006-3074-02	ZEPATIER	2 in 1 CARTON	TABLET, FILM COATED	2		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-3074-01	EA - Each	0006-3074	ebd4b458-b786-4313-bf95-207cbfac3a4f	1	2016-03-04
0006-3074-02	EA - Each	0006-3074	ca7f83dc-cc0c-44cc-9c71-94737912a670	1	2016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0006-3074	ZEPATIER (ELBASVIR AND GRAZOPREVIR) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]	20	Current NDC, Legacy NDC, 2 package rows	20240713_164dc02a-9180-426a-b8b5-04ab39d2bbd4.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
ZEPATIER	ELBASVIR AND GRAZOPREVIR	Merck Sharp & Dohme LLC	164dc02a-9180-426a-b8b5-04ab39d2bbd4	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208261 application number: NDA208261 ndc (product): 0006-3074

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
632L571YDK	ELBASVIR	1370468-36-2	ELBASVIR
8YE81R1X1J	GRAZOPREVIR ANHYDROUS	1350514-68-9	GRAZOPREVIR ANHYDROUS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1734636	elbasvir 50 MG / grazoprevir 100 MG Oral Tablet	PSN	164dc02a-9180-426a-b8b5-04ab39d2bbd4	22
1734642	Zepatier 50 MG / 100 MG Oral Tablet	PSN	164dc02a-9180-426a-b8b5-04ab39d2bbd4	22
1734642	elbasvir 50 MG / grazoprevir 100 MG Oral Tablet [Zepatier]	SBD	164dc02a-9180-426a-b8b5-04ab39d2bbd4	22
1734636	elbasvir 50 MG / grazoprevir 100 MG Oral Tablet	SCD	164dc02a-9180-426a-b8b5-04ab39d2bbd4	22
1734642	Zepatier (elbasvir 50 MG / grazoprevir 100 MG) Oral Tablet	SY	164dc02a-9180-426a-b8b5-04ab39d2bbd4	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0006-3074-01	00006307401	14 in 1 DOSE PACK						Historical
0006-3074-02	00006307402	2 DOSE PACK in 1 CARTON (0006-3074-02) / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01)	2 dose pack	2016-01-28	0000-00-00	No	No	Current