Application 214377

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VERQUVOVERICIGUATTABLET;ORAL2.5MGYesNo
002VERQUVOVERICIGUATTABLET;ORAL5MGYesNo
003VERQUVOVERICIGUATTABLET;ORAL10MGYesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214377-001VERQUVOVERICIGUAT2.5MGTABLET / ORALRLD2021-01-19
N214377-002VERQUVOVERICIGUAT5MGTABLET / ORALRLD2021-01-19
N214377-003VERQUVOVERICIGUAT10MGTABLET / ORALRLD, RS2021-01-19

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214377-001107368962031-05-19Drug substance, Drug product2021-02-12
N214377-001114396422031-05-19U-30622022-10-11
N214377-00184206562031-05-19Drug substance, Drug product2021-02-12
N214377-00189213772031-05-19U-30622021-02-12
N214377-00199934762031-05-19U-30622021-02-12
N214377-00196049482032-11-26U-3062Drug substance, Drug product2021-02-12
N214377-002107368962031-05-19Drug substance, Drug product2021-02-12
N214377-002114396422031-05-19U-30622022-10-11
N214377-00284206562031-05-19Drug substance, Drug product2021-02-12
N214377-00289213772031-05-19U-30622021-02-12
N214377-00299934762031-05-19U-30622021-02-12
N214377-00296049482032-11-26U-3062Drug substance, Drug product2021-02-12
N214377-003107368962031-05-19Drug substance, Drug product2021-02-12
N214377-003114396422031-05-19U-30622022-10-11
N214377-00384206562031-05-19Drug substance, Drug product2021-02-12
N214377-00389213772031-05-19U-30622021-02-12
N214377-00399934762031-05-19U-30622021-02-12
N214377-00396049482032-11-26U-3062Drug substance, Drug product2021-02-12

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N214377-001NCE2026-01-19
N214377-001D-1982029-01-21
N214377-002NCE2026-01-19
N214377-002D-1982029-01-21
N214377-003NCE2026-01-19
N214377-003D-1982029-01-21

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N214377-001VERQUVO2.5MGTABLET / ORALRLD2021-01-19caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-002VERQUVO5MGTABLET / ORALRLD2021-01-19caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-003VERQUVO10MGTABLET / ORALRLD, RS2021-01-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214377-001VERQUVO2.5MGTABLET / ORALRLD2021-01-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-002VERQUVO5MGTABLET / ORALRLD2021-01-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-003VERQUVO10MGTABLET / ORALRLD, RS2021-01-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214377-001VERQUVO2.5MGTABLET / ORALRLD2021-01-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214377-002VERQUVO5MGTABLET / ORALRLD2021-01-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214377-003VERQUVO10MGTABLET / ORALRLD, RS2021-01-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N214377-001VERQUVO2.5MGTABLET / ORALRLD2021-01-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214377-002VERQUVO5MGTABLET / ORALRLD2021-01-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214377-003VERQUVO10MGTABLET / ORALRLD, RS2021-01-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214377-001VERQUVO2.5MGTABLET / ORALRLD2021-01-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214377-002VERQUVO5MGTABLET / ORALRLD2021-01-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214377-003VERQUVO10MGTABLET / ORALRLD, RS2021-01-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214377-001VERQUVO2.5MGTABLET / ORALRLD2021-01-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214377-002VERQUVO5MGTABLET / ORALRLD2021-01-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214377-003VERQUVO10MGTABLET / ORALRLD, RS2021-01-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214377-001VERQUVO2.5MGTABLET / ORALRLD2021-01-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214377-002VERQUVO5MGTABLET / ORALRLD2021-01-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214377-003VERQUVO10MGTABLET / ORALRLD, RS2021-01-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214377-001VERQUVO2.5MGTABLET / ORALRLD2021-01-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214377-002VERQUVO5MGTABLET / ORALRLD2021-01-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214377-003VERQUVO10MGTABLET / ORALRLD, RS2021-01-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214377-001VERQUVO2.5MGTABLET / ORALRLD2021-01-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214377-002VERQUVO5MGTABLET / ORALRLD2021-01-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214377-003VERQUVO10MGTABLET / ORALRLD, RS2021-01-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214377-001VERQUVO2.5MGTABLET / ORALRLD2021-01-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214377-002VERQUVO5MGTABLET / ORALRLD2021-01-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214377-003VERQUVO10MGTABLET / ORALRLD, RS2021-01-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214377-001VERQUVO2.5MGTABLET / ORALRLD2021-01-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N214377-002VERQUVO5MGTABLET / ORALRLD2021-01-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N214377-003VERQUVO10MGTABLET / ORALRLD, RS2021-01-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214377-001VERQUVO2.5MGTABLET / ORALRLD2021-01-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214377-002VERQUVO5MGTABLET / ORALRLD2021-01-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214377-003VERQUVO10MGTABLET / ORALRLD, RS2021-01-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214377-001VERQUVO2.5MGTABLET / ORALRLD2021-01-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214377-002VERQUVO5MGTABLET / ORALRLD2021-01-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214377-003VERQUVO10MGTABLET / ORALRLD, RS2021-01-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214377-001VERQUVO2.5MGTABLET / ORALRLD2021-01-191e350fbaab3a…

Observed Orange Book patent history#

Patent history page 1 of 16 · 606 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N214377-001107368962031-05-19Drug substance, Drug product2021-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-001114396422031-05-19U-30622022-10-11caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-00184206562031-05-19Drug substance, Drug product2021-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-00189213772031-05-19U-30622021-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-00199934762031-05-19U-30622021-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-00196049482032-11-26U-3062Drug substance, Drug product2021-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-002107368962031-05-19Drug substance, Drug product2021-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-002114396422031-05-19U-30622022-10-11caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-00284206562031-05-19Drug substance, Drug product2021-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-00289213772031-05-19U-30622021-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-00299934762031-05-19U-30622021-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-00296049482032-11-26U-3062Drug substance, Drug product2021-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-003107368962031-05-19Drug substance, Drug product2021-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-003114396422031-05-19U-30622022-10-11caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-00384206562031-05-19Drug substance, Drug product2021-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-00389213772031-05-19U-30622021-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-00399934762031-05-19U-30622021-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-00396049482032-11-26U-3062Drug substance, Drug product2021-02-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214377-001107368962031-05-19Drug substance, Drug product2021-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-001114396422031-05-19U-30622022-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-00184206562031-05-19Drug substance, Drug product2021-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-00189213772031-05-19U-30622021-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-00199934762031-05-19U-30622021-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-00196049482032-11-26U-3062Drug substance, Drug product2021-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-002107368962031-05-19Drug substance, Drug product2021-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-002114396422031-05-19U-30622022-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-00284206562031-05-19Drug substance, Drug product2021-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-00289213772031-05-19U-30622021-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-00299934762031-05-19U-30622021-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-00296049482032-11-26U-3062Drug substance, Drug product2021-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-003107368962031-05-19Drug substance, Drug product2021-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-003114396422031-05-19U-30622022-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-00384206562031-05-19Drug substance, Drug product2021-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-00389213772031-05-19U-30622021-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-00399934762031-05-19U-30622021-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-00396049482032-11-26U-3062Drug substance, Drug product2021-02-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214377-001107368962031-05-19Drug substance, Drug product2021-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214377-001114396422031-05-19U-30622022-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214377-00184206562031-05-19Drug substance, Drug product2021-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214377-00189213772031-05-19U-30622021-02-1231067a03dcf5…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N214377-001NCE2026-01-19caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-001D-1982029-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-002NCE2026-01-19caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-002D-1982029-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-003NCE2026-01-19caaa826d4ba7…
2026-08-18 06:07:402026-07N214377-003D-1982029-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214377-001NCE2026-01-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-002NCE2026-01-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214377-003NCE2026-01-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214377-001NCE2026-01-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214377-002NCE2026-01-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214377-003NCE2026-01-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N214377-001NCE2026-01-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214377-002NCE2026-01-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214377-003NCE2026-01-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214377-001NCE2026-01-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214377-002NCE2026-01-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214377-003NCE2026-01-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214377-001NCE2026-01-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214377-002NCE2026-01-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214377-003NCE2026-01-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214377-001NCE2026-01-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214377-002NCE2026-01-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214377-003NCE2026-01-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214377-001NCE2026-01-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214377-002NCE2026-01-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214377-003NCE2026-01-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214377-001NCE2026-01-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214377-002NCE2026-01-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214377-003NCE2026-01-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214377-001NCE2026-01-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214377-002NCE2026-01-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214377-003NCE2026-01-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214377-001NCE2026-01-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N214377-002NCE2026-01-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N214377-003NCE2026-01-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214377-001NCE2026-01-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214377-002NCE2026-01-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214377-003NCE2026-01-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214377-001NCE2026-01-19301d65b070ca…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VERQUVOVERICIGUATMerck Sharp & Dohme LLC17056d73-1b1b-4bf2-9c07-b7a9367f0d6d2026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 214377
application number: NDA214377
ndc (product): 0006-5028
ndc (product): 0006-5029
ndc (product): 0006-5030

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-5028VERQUVOvericiguatMerck Sharp & Dohme Corp.NDACurrent
0006-5028VERQUVOvericiguatMerck Sharp & Dohme Corp.NDACurrent
0006-5028VERQUVOvericiguatMerck Sharp & Dohme LLCNDACurrent
0006-5028VERQUVOvericiguatMerck Sharp & Dohme LLCNDACurrent
0006-5029VERQUVOvericiguatMerck Sharp & Dohme Corp.NDACurrent
0006-5029VERQUVOvericiguatMerck Sharp & Dohme Corp.NDACurrent
0006-5029VERQUVOvericiguatMerck Sharp & Dohme LLCNDACurrent
0006-5029VERQUVOvericiguatMerck Sharp & Dohme LLCNDACurrent
0006-5030VERQUVOvericiguatMerck Sharp & Dohme Corp.NDACurrent
0006-5030VERQUVOvericiguatMerck Sharp & Dohme Corp.NDACurrent
0006-5030VERQUVOvericiguatMerck Sharp & Dohme LLCNDACurrent
0006-5030VERQUVOvericiguatMerck Sharp & Dohme LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84822SUPPL 2026-01-22
84817SUPPL 2026-01-22
74227SUPPL 2023-05-11
74226SUPPL 2023-05-11
74220SUPPL 2023-05-11
72721SUPPL2022-11-27
72715SUPPL2022-11-25
66264ORIG2021-02-17
65949ORIG2021-01-21
65943ORIG2021-01-19