FDA.reportPublic FDA data

VERAPAMIL HYDROCHLORIDE

Product NDC
68071-4635
11-digit product format
680714635
Labeler code
68071
Product ID
68071-4635_1ab7ca71-6c7e-a8cb-e063-6394a90a07fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VERAPAMIL HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA071881
Marketing category
ANDA
Marketing start
2018-07-20
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
120 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VERAPAMIL HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VERAPAMIL HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV3888OEY5R
Rxcui897666

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
68071-4635-92024-06-12C16284748780-1ba0f9c33-1a3c-a910-e053-dadaa90a0b85Verapamil Hydrochloride Tablets, USP 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:
68071-4635-92023-01-30C16284748780-1ba0f9c33-1a3c-a910-e053-dadaa90a0b85Verapamil Hydrochloride Tablets, USP 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:
68071-4635-92021-02-22C16284748780-1ba0f9c33-1a3c-a910-e053-dadaa90a0b85Verapamil Hydrochloride Tablets, USP 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:
68071-4635-92021-01-29C16284748780-1ba0f9c33-1a3c-a910-e053-dadaa90a0b85Verapamil Hydrochloride Tablets, USP 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
68071-4635-9VERAPAMIL HYDROCHLORIDE90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4635VERAPAMIL HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240614_7b321aa1-1b53-26d5-e053-2991aa0a1373.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897666verapamil HCl 120 MG Oral TabletPSN7b321aa1-1b53-26d5-e053-2991aa0a13734
897666verapamil hydrochloride 120 MG Oral TabletSCD7b321aa1-1b53-26d5-e053-2991aa0a13734

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4635-96807146350990 TABLET in 1 BOTTLE (68071-4635-9) 90 tablet2018-11-210000-00-00NoNoCurrent