Home Applications 214377 Application 214377
Type NDA
Sponsor MERCK SHARP DOHME Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VERQUVO VERICIGUAT TABLET;ORAL 2.5MG Yes No 002 VERQUVO VERICIGUAT TABLET;ORAL 5MG Yes No 003 VERQUVO VERICIGUAT TABLET;ORAL 10MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214377-001 VERQUVO VERICIGUAT 2.5MG TABLET / ORAL RLD 2021-01-19 N214377-002 VERQUVO VERICIGUAT 5MG TABLET / ORAL RLD 2021-01-19 N214377-003 VERQUVO VERICIGUAT 10MG TABLET / ORAL RLD, RS 2021-01-19
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214377-001 10736896 2031-05-19 Drug substance, Drug product 2021-02-12 N214377-001 11439642 2031-05-19 U-3062 2022-10-11 N214377-001 8420656 2031-05-19 Drug substance, Drug product 2021-02-12 N214377-001 8921377 2031-05-19 U-3062 2021-02-12 N214377-001 9993476 2031-05-19 U-3062 2021-02-12 N214377-001 9604948 2032-11-26 U-3062 Drug substance, Drug product 2021-02-12 N214377-002 10736896 2031-05-19 Drug substance, Drug product 2021-02-12 N214377-002 11439642 2031-05-19 U-3062 2022-10-11 N214377-002 8420656 2031-05-19 Drug substance, Drug product 2021-02-12 N214377-002 8921377 2031-05-19 U-3062 2021-02-12 N214377-002 9993476 2031-05-19 U-3062 2021-02-12 N214377-002 9604948 2032-11-26 U-3062 Drug substance, Drug product 2021-02-12 N214377-003 10736896 2031-05-19 Drug substance, Drug product 2021-02-12 N214377-003 11439642 2031-05-19 U-3062 2022-10-11 N214377-003 8420656 2031-05-19 Drug substance, Drug product 2021-02-12 N214377-003 8921377 2031-05-19 U-3062 2021-02-12 N214377-003 9993476 2031-05-19 U-3062 2021-02-12 N214377-003 9604948 2032-11-26 U-3062 Drug substance, Drug product 2021-02-12
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
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 3 · 108 observed 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 N214377-001 VERQUVO 2.5MG TABLET / ORAL RLD 2021-01-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-002 VERQUVO 5MG TABLET / ORAL RLD 2021-01-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-003 VERQUVO 10MG TABLET / ORAL RLD, RS 2021-01-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214377-001 VERQUVO 2.5MG TABLET / ORAL RLD 2021-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-002 VERQUVO 5MG TABLET / ORAL RLD 2021-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-003 VERQUVO 10MG TABLET / ORAL RLD, RS 2021-01-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214377-001 VERQUVO 2.5MG TABLET / ORAL RLD 2021-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214377-002 VERQUVO 5MG TABLET / ORAL RLD 2021-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214377-003 VERQUVO 10MG TABLET / ORAL RLD, RS 2021-01-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214377-001 VERQUVO 2.5MG TABLET / ORAL RLD 2021-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214377-002 VERQUVO 5MG TABLET / ORAL RLD 2021-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214377-003 VERQUVO 10MG TABLET / ORAL RLD, RS 2021-01-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214377-001 VERQUVO 2.5MG TABLET / ORAL RLD 2021-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214377-002 VERQUVO 5MG TABLET / ORAL RLD 2021-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214377-003 VERQUVO 10MG TABLET / ORAL RLD, RS 2021-01-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214377-001 VERQUVO 2.5MG TABLET / ORAL RLD 2021-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214377-002 VERQUVO 5MG TABLET / ORAL RLD 2021-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214377-003 VERQUVO 10MG TABLET / ORAL RLD, RS 2021-01-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214377-001 VERQUVO 2.5MG TABLET / ORAL RLD 2021-01-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214377-002 VERQUVO 5MG TABLET / ORAL RLD 2021-01-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214377-003 VERQUVO 10MG TABLET / ORAL RLD, RS 2021-01-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214377-001 VERQUVO 2.5MG TABLET / ORAL RLD 2021-01-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214377-002 VERQUVO 5MG TABLET / ORAL RLD 2021-01-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214377-003 VERQUVO 10MG TABLET / ORAL RLD, RS 2021-01-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214377-001 VERQUVO 2.5MG TABLET / ORAL RLD 2021-01-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214377-002 VERQUVO 5MG TABLET / ORAL RLD 2021-01-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214377-003 VERQUVO 10MG TABLET / ORAL RLD, RS 2021-01-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214377-001 VERQUVO 2.5MG TABLET / ORAL RLD 2021-01-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214377-002 VERQUVO 5MG TABLET / ORAL RLD 2021-01-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214377-003 VERQUVO 10MG TABLET / ORAL RLD, RS 2021-01-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214377-001 VERQUVO 2.5MG TABLET / ORAL RLD 2021-01-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214377-002 VERQUVO 5MG TABLET / ORAL RLD 2021-01-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214377-003 VERQUVO 10MG TABLET / ORAL RLD, RS 2021-01-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214377-001 VERQUVO 2.5MG TABLET / ORAL RLD 2021-01-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214377-002 VERQUVO 5MG TABLET / ORAL RLD 2021-01-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214377-003 VERQUVO 10MG TABLET / ORAL RLD, RS 2021-01-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214377-001 VERQUVO 2.5MG TABLET / ORAL RLD 2021-01-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214377-002 VERQUVO 5MG TABLET / ORAL RLD 2021-01-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214377-003 VERQUVO 10MG TABLET / ORAL RLD, RS 2021-01-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214377-001 VERQUVO 2.5MG TABLET / ORAL RLD 2021-01-19 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 16 · 606 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 N214377-001 10736896 2031-05-19 Drug substance, Drug product 2021-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-001 11439642 2031-05-19 U-3062 2022-10-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-001 8420656 2031-05-19 Drug substance, Drug product 2021-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-001 8921377 2031-05-19 U-3062 2021-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-001 9993476 2031-05-19 U-3062 2021-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-001 9604948 2032-11-26 U-3062 Drug substance, Drug product 2021-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-002 10736896 2031-05-19 Drug substance, Drug product 2021-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-002 11439642 2031-05-19 U-3062 2022-10-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-002 8420656 2031-05-19 Drug substance, Drug product 2021-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-002 8921377 2031-05-19 U-3062 2021-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-002 9993476 2031-05-19 U-3062 2021-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-002 9604948 2032-11-26 U-3062 Drug substance, Drug product 2021-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-003 10736896 2031-05-19 Drug substance, Drug product 2021-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-003 11439642 2031-05-19 U-3062 2022-10-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-003 8420656 2031-05-19 Drug substance, Drug product 2021-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-003 8921377 2031-05-19 U-3062 2021-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-003 9993476 2031-05-19 U-3062 2021-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214377-003 9604948 2032-11-26 U-3062 Drug substance, Drug product 2021-02-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214377-001 10736896 2031-05-19 Drug substance, Drug product 2021-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-001 11439642 2031-05-19 U-3062 2022-10-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-001 8420656 2031-05-19 Drug substance, Drug product 2021-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-001 8921377 2031-05-19 U-3062 2021-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-001 9993476 2031-05-19 U-3062 2021-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-001 9604948 2032-11-26 U-3062 Drug substance, Drug product 2021-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-002 10736896 2031-05-19 Drug substance, Drug product 2021-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-002 11439642 2031-05-19 U-3062 2022-10-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-002 8420656 2031-05-19 Drug substance, Drug product 2021-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-002 8921377 2031-05-19 U-3062 2021-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-002 9993476 2031-05-19 U-3062 2021-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-002 9604948 2032-11-26 U-3062 Drug substance, Drug product 2021-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-003 10736896 2031-05-19 Drug substance, Drug product 2021-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-003 11439642 2031-05-19 U-3062 2022-10-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-003 8420656 2031-05-19 Drug substance, Drug product 2021-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-003 8921377 2031-05-19 U-3062 2021-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-003 9993476 2031-05-19 U-3062 2021-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214377-003 9604948 2032-11-26 U-3062 Drug substance, Drug product 2021-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214377-001 10736896 2031-05-19 Drug substance, Drug product 2021-02-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214377-001 11439642 2031-05-19 U-3062 2022-10-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214377-001 8420656 2031-05-19 Drug substance, Drug product 2021-02-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214377-001 8921377 2031-05-19 U-3062 2021-02-12 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 114 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-5028 VERQUVO vericiguat Merck Sharp & Dohme Corp. NDA Current 0006-5028 VERQUVO vericiguat Merck Sharp & Dohme Corp. NDA Current 0006-5028 VERQUVO vericiguat Merck Sharp & Dohme LLC NDA Current 0006-5028 VERQUVO vericiguat Merck Sharp & Dohme LLC NDA Current 0006-5029 VERQUVO vericiguat Merck Sharp & Dohme Corp. NDA Current 0006-5029 VERQUVO vericiguat Merck Sharp & Dohme Corp. NDA Current 0006-5029 VERQUVO vericiguat Merck Sharp & Dohme LLC NDA Current 0006-5029 VERQUVO vericiguat Merck Sharp & Dohme LLC NDA Current 0006-5030 VERQUVO vericiguat Merck Sharp & Dohme Corp. NDA Current 0006-5030 VERQUVO vericiguat Merck Sharp & Dohme Corp. NDA Current 0006-5030 VERQUVO vericiguat Merck Sharp & Dohme LLC NDA Current 0006-5030 VERQUVO vericiguat Merck Sharp & Dohme LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 84822 SUPPL 2026-01-22 84817 SUPPL 2026-01-22 74227 SUPPL 2023-05-11 74226 SUPPL 2023-05-11 74220 SUPPL 2023-05-11 72721 SUPPL 2022-11-27 72715 SUPPL 2022-11-25 66264 ORIG 2021-02-17 65949 ORIG 2021-01-21 65943 ORIG 2021-01-19