FDA.reportPublic FDA data

VERAPAMIL HYDROCHLORIDE

Product NDC
42291-854
11-digit product format
422910854
Labeler code
42291
Product ID
42291-854_4875cced-75af-ed7f-e063-6294a90addfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VERAPAMIL HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA071881
Marketing category
ANDA
Marketing start
2020-04-13
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VERAPAMIL HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV3888OEY5R
Rxcui897666, 897683, 897722

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea1f6fc8-bfc2-4421-a2eb-4e87c7c3e3c4Product name220230103
33ad674d-d105-6aa5-02fa-95ae4329b8cdProduct name220180809
3279bd6d-5b02-e60b-3857-c853a2deb2ddProduct name220170713
8ebb66e3-d7b3-f1e5-88aa-3369e64bb84aProduct name120140508
940a1faa-2df8-cc65-be37-1b97984b4ea3Product name120140508
d3b67bc2-0e96-e3ec-06a9-90afcc07bf13Product name120140508
e2fcd66c-a043-3187-790d-b0342deb1149Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42291-854-012022-02-03C16284748780-1d6a99b39-8936-a426-e053-dadaa90af4c2Verapamil Hydrochloride Tablets, USP Rx Only These highlights do not include all the information needed to use VERAPAMIL HYDROCHLORIDE safely and effectively. See full prescribing information for VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET for ORAL use. Initial U.S. Approval:
42291-854-012022-01-28C16284748780-1d6a99b39-8936-a426-e053-dadaa90af4c2Verapamil Hydrochloride Tablets, USP Rx Only These highlights do not include all the information needed to use VERAPAMIL HYDROCHLORIDE safely and effectively. See full prescribing information for VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET for ORAL use. Initial U.S. Approval:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-854-01VERAPAMIL HYDROCHLORIDE100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-854-01EA - Each42291-854f8a4d862-1fe8-4f0d-bf50-f46f1ec3ef7012020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-854VERAPAMIL HYDROCHLORIDE TABLET [AVKARE]3Current NDC, Legacy NDC, 1 package rows20240111_a32f346e-71cf-cc11-e053-2a95a90ae88c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897666verapamil HCl 120 MG Oral TabletPSNa32f346e-71cf-cc11-e053-2a95a90ae88c4
897722verapamil HCl 40 MG Oral TabletPSNa32f346e-71cf-cc11-e053-2a95a90ae88c4
897683verapamil HCl 80 MG Oral TabletPSNa32f346e-71cf-cc11-e053-2a95a90ae88c4
897666verapamil hydrochloride 120 MG Oral TabletSCDa32f346e-71cf-cc11-e053-2a95a90ae88c4
897722verapamil hydrochloride 40 MG Oral TabletSCDa32f346e-71cf-cc11-e053-2a95a90ae88c4
897683verapamil hydrochloride 80 MG Oral TabletSCDa32f346e-71cf-cc11-e053-2a95a90ae88c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-854-0142291085401100 TABLET in 1 BOTTLE (42291-854-01) 100 tablet2020-04-130000-00-00NoNoCurrent