FDA.reportPublic FDA data

VERQUVO

Product NDC
0006-5029
11-digit product format
000065029
Labeler code
0006
Product ID
0006-5029_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
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
VERICIGUAT5 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
0006-5029-012024-01-30C16284748780-11030e365-64a7-111a-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
0006-5029-012024-01-30C16284748780-11030e365-64a7-111a-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
0006-5029-012024-01-30C16284748780-11030e365-64a7-111a-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
0006-5029-022024-01-30C16284748780-11030e365-64a7-111a-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
0006-5029-022024-01-30C16284748780-11030e365-64a7-111a-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
0006-5029-022024-01-30C16284748780-11030e365-64a7-111a-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
0006-5029-042024-01-30C16284748780-11030e365-64a7-111a-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
0006-5029-042024-01-30C16284748780-11030e365-64a7-111a-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
0006-5029-042024-01-30C16284748780-11030e365-64a7-111a-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
0006-5029-062024-01-30C16284748780-11030e365-64a7-111a-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
0006-5029-062024-01-30C16284748780-11030e365-64a7-111a-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
0006-5029-062024-01-30C16284748780-11030e365-64a7-111a-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
0006-5029-01VERQUVO14 in 1 BOTTLETABLET, FILM COATED1413
0006-5029-02VERQUVO30 in 1 BOTTLETABLET, FILM COATED3013
0006-5029-03VERQUVO10 in 1 BLISTER PACKTABLET, FILM COATED1013
0006-5029-04VERQUVO10 in 1 CARTONTABLET, FILM COATED1013
0006-5029-05VERQUVO14 in 1 BOTTLETABLET, FILM COATED1413
0006-5029-06VERQUVO1 in 1 CARTONTABLET, FILM COATED113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-5029-01EA - Each0006-50295b67ff1f-88e9-4fe5-9ee3-03605a91eff612021-02-05
0006-5029-02EA - Each0006-50297e5bbb76-56a9-46b3-a899-756508975b7912021-02-05
0006-5029-03EA - Each0006-5029d6394f42-aba6-47c4-95aa-c7e1a38938c112023-04-07
0006-5029-04EA - Each0006-50296c957c61-fad2-4d5b-87e1-91ccaddc338012021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-5029VERQUVO (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
0006-5029-010000650290114 TABLET, FILM COATED in 1 BOTTLE (0006-5029-01) 2021-02-010000-00-00NoNoCurrent
0006-5029-020000650290230 TABLET, FILM COATED in 1 BOTTLE (0006-5029-02) 2021-02-010000-00-00NoNoCurrent
0006-5029-030000650290310 in 1 BLISTER PACKHistorical
0006-5029-040000650290410 BLISTER PACK in 1 CARTON (0006-5029-04) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0006-5029-03) 10 blister pack2021-02-010000-00-00NoNoCurrent
0006-5029-050000650290514 TABLET, FILM COATED in 1 BOTTLE (0006-5029-05) 2021-02-010000-00-00NoNoCurrent
0006-5029-06000065029061 BOTTLE in 1 CARTON (0006-5029-06) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-5029-05) 1 bottle2021-02-01YesNoCurrent