FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VERICIGUAT2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLV66ADM269
Rxcui2475846, 2475852, 2475854, 2475856, 2475858, 2475860

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b1b37e6f-e9b7-486d-84e9-197ea1eba21aProduct name120210621

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0006-5028-012024-01-30C16284748780-11030e365-64a7-111a-e063-dadaa90a10e2These 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
0006-5028-012024-01-30C16284748780-11030e365-64a7-111a-e063-dadaa90a10e2These 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
0006-5028-012024-01-30C16284748780-11030e365-64a7-111a-e063-dadaa90a10e2These 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
0006-5028-022024-01-30C16284748780-11030e365-64a7-111a-e063-dadaa90a10e2These 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
0006-5028-022024-01-30C16284748780-11030e365-64a7-111a-e063-dadaa90a10e2These 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
0006-5028-022024-01-30C16284748780-11030e365-64a7-111a-e063-dadaa90a10e2These 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
0006-5028-042024-01-30C16284748780-11030e365-64a7-111a-e063-dadaa90a10e2These 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
0006-5028-042024-01-30C16284748780-11030e365-64a7-111a-e063-dadaa90a10e2These 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
0006-5028-042024-01-30C16284748780-11030e365-64a7-111a-e063-dadaa90a10e2These 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
0006-5028-062024-01-30C16284748780-11030e365-64a7-111a-e063-dadaa90a10e2These 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
0006-5028-062024-01-30C16284748780-11030e365-64a7-111a-e063-dadaa90a10e2These 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
0006-5028-062024-01-30C16284748780-11030e365-64a7-111a-e063-dadaa90a10e2These 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 NDCProductDescriptionFormQuantityStrengthSPL version
0006-5028-01VERQUVO14 in 1 BOTTLETABLET, FILM COATED1413
0006-5028-02VERQUVO30 in 1 BOTTLETABLET, FILM COATED3013
0006-5028-03VERQUVO10 in 1 BLISTER PACKTABLET, FILM COATED1013
0006-5028-04VERQUVO10 in 1 CARTONTABLET, FILM COATED1013
0006-5028-05VERQUVO14 in 1 BOTTLETABLET, FILM COATED1413
0006-5028-06VERQUVO1 in 1 CARTONTABLET, FILM COATED113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-5028-01EA - Each0006-50285bc127db-02be-4010-9e3c-cd9f117de7f612021-02-05
0006-5028-02EA - Each0006-5028d7964275-f358-40aa-b443-205d2a38fefd12021-02-05
0006-5028-03EA - Each0006-50287b0b0185-49b9-413a-b9d4-cba828154a3812023-04-07
0006-5028-04EA - Each0006-5028d7165cf2-e24c-4769-b416-637788f2506c12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-5028VERQUVO (VERICIGUAT) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]10Current NDC, Legacy NDC, 6 package rows20241116_17056d73-1b1b-4bf2-9c07-b7a9367f0d6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2475846vericiguat 10 MG Oral TabletPSN17056d73-1b1b-4bf2-9c07-b7a9367f0d6d13
2475854vericiguat 2.5 MG Oral TabletPSN17056d73-1b1b-4bf2-9c07-b7a9367f0d6d13
2475858vericiguat 5 MG Oral TabletPSN17056d73-1b1b-4bf2-9c07-b7a9367f0d6d13
2475852Verquvo 10 MG Oral TabletPSN17056d73-1b1b-4bf2-9c07-b7a9367f0d6d13
2475856Verquvo 2.5 MG Oral TabletPSN17056d73-1b1b-4bf2-9c07-b7a9367f0d6d13
2475860Verquvo 5 MG Oral TabletPSN17056d73-1b1b-4bf2-9c07-b7a9367f0d6d13
2475852vericiguat 10 MG Oral Tablet [Verquvo]SBD17056d73-1b1b-4bf2-9c07-b7a9367f0d6d13
2475856vericiguat 2.5 MG Oral Tablet [Verquvo]SBD17056d73-1b1b-4bf2-9c07-b7a9367f0d6d13
2475860vericiguat 5 MG Oral Tablet [Verquvo]SBD17056d73-1b1b-4bf2-9c07-b7a9367f0d6d13
2475846vericiguat 10 MG Oral TabletSCD17056d73-1b1b-4bf2-9c07-b7a9367f0d6d13
2475854vericiguat 2.5 MG Oral TabletSCD17056d73-1b1b-4bf2-9c07-b7a9367f0d6d13
2475858vericiguat 5 MG Oral TabletSCD17056d73-1b1b-4bf2-9c07-b7a9367f0d6d13
2475852Verquvo 10 MG Oral TabletSY17056d73-1b1b-4bf2-9c07-b7a9367f0d6d13
2475856Verquvo 2.5 MG Oral TabletSY17056d73-1b1b-4bf2-9c07-b7a9367f0d6d13
2475860Verquvo 5 MG Oral TabletSY17056d73-1b1b-4bf2-9c07-b7a9367f0d6d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-5028-010000650280114 TABLET, FILM COATED in 1 BOTTLE (0006-5028-01) 2021-02-010000-00-00NoNoCurrent
0006-5028-020000650280230 TABLET, FILM COATED in 1 BOTTLE (0006-5028-02) 2021-02-010000-00-00NoNoCurrent
0006-5028-030000650280310 in 1 BLISTER PACKHistorical
0006-5028-040000650280410 BLISTER PACK in 1 CARTON (0006-5028-04) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0006-5028-03) 10 blister pack2021-02-010000-00-00NoNoCurrent
0006-5028-050000650280514 TABLET, FILM COATED in 1 BOTTLE (0006-5028-05) 2021-02-010000-00-00NoNoCurrent
0006-5028-06000065028061 BOTTLE in 1 CARTON (0006-5028-06) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-5028-05) 1 bottle2023-04-01YesNoCurrent