FDA.reportPublic FDA data

verapamil hydrochloride

Product NDC
50090-0584
11-digit product format
500900584
Labeler code
50090
Product ID
50090-0584_345c643b-a853-4818-8559-619c7d5e978e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090700
Marketing category
ANDA
Marketing start
2011-08-05
Marketing end
0000-00-00
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
P-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
50090-0584-02023-01-30C16284748780-1f386c64a-374b-0266-e053-dadaa90a7c1aVerapamil Hydrochloride Extended-Release Tablets
50090-0584-42023-01-30C16284748780-1f386c64a-374b-0266-e053-dadaa90a7c1aVerapamil Hydrochloride Extended-Release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0584-0verapamil hydrochloride7 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE711
50090-0584-4verapamil hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0584-4EA - Each50090-058468403363-cd59-402d-9914-e6e38f809a7d12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0584VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]11Legacy NDC, 2 package rows20210416_87f25fef-a8f0-44b2-bc85-3970dad87ebb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897640verapamil HCl 180 MG Extended Release Oral TabletPSN87f25fef-a8f0-44b2-bc85-3970dad87ebb11
897640verapamil hydrochloride 180 MG Extended Release Oral TabletSCD87f25fef-a8f0-44b2-bc85-3970dad87ebb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0584-0500900584007 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-0584-0) 2018-12-260000-00-00NoNoCurrent
50090-0584-45009005840430 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-0584-4) 2014-11-280000-00-00NoNoCurrent