FDA.reportPublic FDA data

verapamil hydrochloride

Product NDC
68071-3446
11-digit product format
680713446
Labeler code
68071
Product ID
68071-3446_2d5a1708-0550-2db5-e063-6294a90a0fe7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090700
Marketing category
ANDA
Marketing start
2011-08-05
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
Rxcui897659

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
68071-3446-02025-02-04C16284748780-12cef2736-b414-d83d-e063-dadaa90ab31fVerapamil Hydrochloride Extended-Release Tablets, USP
68071-3446-02025-01-30C16284748780-12cef2736-b414-d83d-e063-dadaa90ab31fVerapamil Hydrochloride Extended-Release Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3446-0verapamil hydrochloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3446VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250206_febce7aa-7f5a-e0c1-e053-6394a90aebc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897659verapamil HCl 120 MG Extended Release Oral TabletPSNfebce7aa-7f5a-e0c1-e053-6394a90aebc42
897659verapamil hydrochloride 120 MG Extended Release Oral TabletSCDfebce7aa-7f5a-e0c1-e053-6394a90aebc42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3446-068071344600100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68071-3446-0) 2023-06-22NoNoCurrent