FDA.reportPublic FDA data

verapamil hydrochloride

Product NDC
71610-258
11-digit product format
716100258
Labeler code
71610
Product ID
71610-258_8904da5a-905a-4d9b-9591-f5086aafb669
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
2020-12-31
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
71610-258-602023-01-30C16284748780-1f386c649-a8c3-0266-e053-dadaa90a7c1aVerapamil Hydrochloride Extended-Release Tablets USP
71610-258-802023-01-30C16284748780-1f386c649-a8c3-0266-e053-dadaa90a7c1aVerapamil Hydrochloride Extended-Release Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-258-60verapamil hydrochloride90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901
71610-258-80verapamil hydrochloride180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-258-60EA - Each71610-258625403e7-636a-49ea-afa2-78bb4de3704c12019-06-19
71610-258-80EA - Each71610-258addb2a10-3882-49de-bac0-03a78bf0d67f12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-258VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20190504_05b1c51a-5fa6-421e-8cbf-6fa1bcf3a60c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897640verapamil HCl 180 MG Extended Release Oral TabletPSN05b1c51a-5fa6-421e-8cbf-6fa1bcf3a60c1
897640verapamil hydrochloride 180 MG Extended Release Oral TabletSCD05b1c51a-5fa6-421e-8cbf-6fa1bcf3a60c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-258-607161002586090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-258-60) 2019-03-290000-00-00NoNoCurrent
71610-258-8071610025880180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-258-80) 2019-03-290000-00-00NoNoCurrent