Home NDC 0006-5028 VERQUVO
Product NDC 0006-5028
11-digit product format 000065028
Labeler code 0006
Product ID 0006-5028_13b78d9a-fa62-4fcf-8a33-233bc48faccb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vericiguat
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Merck Sharp & Dohme LLC
Application NDA214377
Marketing category NDA
Marketing start 2021-02-01
Substance VERICIGUAT
Active strength 2.5 mg/1
Pharmacologic classes Guanylate Cyclase Stimulators [MoA], Soluble Guanylate Cyclase Stimulator [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 · 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.
Additional Listing Data#
Finished product Yes
Brand name base VERQUVO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VERICIGUAT 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LV66ADM269 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2475846 Internal RxNorm lookup 2475852 Internal RxNorm lookup 2475854 Internal RxNorm lookup 2475856 Internal RxNorm lookup 2475858 Internal RxNorm lookup 2475860 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 0006-5028-01 These highlights do not include all the information needed to use VERQUVO safely and effectively. See full prescribing information for VERQUVO. VERQUVO ® (vericiguat) tablets, for oral use Initial U.S. Approval: 2021 0006-5028-01 These highlights do not include all the information needed to use VERQUVO safely and effectively. See full prescribing information for VERQUVO. VERQUVO ® (vericiguat) tablets, for oral use Initial U.S. Approval: 2021 0006-5028-01 These highlights do not include all the information needed to use VERQUVO safely and effectively. See full prescribing information for VERQUVO. VERQUVO ® (vericiguat) tablets, for oral use Initial U.S. Approval: 2021 0006-5028-02 These highlights do not include all the information needed to use VERQUVO safely and effectively. See full prescribing information for VERQUVO. VERQUVO ® (vericiguat) tablets, for oral use Initial U.S. Approval: 2021 0006-5028-02 These highlights do not include all the information needed to use VERQUVO safely and effectively. See full prescribing information for VERQUVO. VERQUVO ® (vericiguat) tablets, for oral use Initial U.S. Approval: 2021 0006-5028-02 These highlights do not include all the information needed to use VERQUVO safely and effectively. See full prescribing information for VERQUVO. VERQUVO ® (vericiguat) tablets, for oral use Initial U.S. Approval: 2021 0006-5028-04 These highlights do not include all the information needed to use VERQUVO safely and effectively. See full prescribing information for VERQUVO. VERQUVO ® (vericiguat) tablets, for oral use Initial U.S. Approval: 2021 0006-5028-04 These highlights do not include all the information needed to use VERQUVO safely and effectively. See full prescribing information for VERQUVO. VERQUVO ® (vericiguat) tablets, for oral use Initial U.S. Approval: 2021 0006-5028-04 These highlights do not include all the information needed to use VERQUVO safely and effectively. See full prescribing information for VERQUVO. VERQUVO ® (vericiguat) tablets, for oral use Initial U.S. Approval: 2021 0006-5028-06 These highlights do not include all the information needed to use VERQUVO safely and effectively. See full prescribing information for VERQUVO. VERQUVO ® (vericiguat) tablets, for oral use Initial U.S. Approval: 2021 0006-5028-06 These highlights do not include all the information needed to use VERQUVO safely and effectively. See full prescribing information for VERQUVO. VERQUVO ® (vericiguat) tablets, for oral use Initial U.S. Approval: 2021 0006-5028-06 These highlights do not include all the information needed to use VERQUVO safely and effectively. See full prescribing information for VERQUVO. VERQUVO ® (vericiguat) tablets, for oral use Initial U.S. Approval: 2021
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0006-5028-01 VERQUVO 14 in 1 BOTTLE TABLET, FILM COATED 14 13 0006-5028-02 VERQUVO 30 in 1 BOTTLE TABLET, FILM COATED 30 13 0006-5028-03 VERQUVO 10 in 1 BLISTER PACK TABLET, FILM COATED 10 13 0006-5028-04 VERQUVO 10 in 1 CARTON TABLET, FILM COATED 10 13 0006-5028-05 VERQUVO 14 in 1 BOTTLE TABLET, FILM COATED 14 13 0006-5028-06 VERQUVO 1 in 1 CARTON TABLET, FILM COATED 1 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-5028 VERQUVO (VERICIGUAT) TABLET, FILM COATED [MERCK SHARP & DOHME LLC] 10 Current NDC, Legacy NDC, 6 package rows 20241116_17056d73-1b1b-4bf2-9c07-b7a9367f0d6d.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 VERQUVO VERICIGUAT Merck Sharp & Dohme LLC 17056d73-1b1b-4bf2-9c07-b7a9367f0d6d 2026-01-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 214377 application number: NDA214377 ndc (product): 0006-5028
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 0006-5028-01 00006502801 14 TABLET, FILM COATED in 1 BOTTLE (0006-5028-01) 2021-02-01 0000-00-00 No No Current 0006-5028-02 00006502802 30 TABLET, FILM COATED in 1 BOTTLE (0006-5028-02) 2021-02-01 0000-00-00 No No Current 0006-5028-03 00006502803 10 in 1 BLISTER PACK Historical 0006-5028-04 00006502804 10 BLISTER PACK in 1 CARTON (0006-5028-04) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0006-5028-03) 10 blister pack 2021-02-01 0000-00-00 No No Current 0006-5028-05 00006502805 14 TABLET, FILM COATED in 1 BOTTLE (0006-5028-05) 2021-02-01 0000-00-00 No No Current 0006-5028-06 00006502806 1 BOTTLE in 1 CARTON (0006-5028-06) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-5028-05) 1 bottle 2023-04-01 Yes No Current