FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
68788-9790
11-digit product format
687889790
Labeler code
68788
Product ID
68788-9790_a8cb0f54-4ce5-488f-a49a-8e7b182b7041
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA078906
Marketing category
ANDA
Marketing start
2012-06-04
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
240 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 HYDROCHLORIDE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV3888OEY5R
Rxcui897649

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-9790-1Verapamil Hydrochloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10011
68788-9790-3Verapamil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3011
68788-9790-6Verapamil Hydrochloride60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6011
68788-9790-9Verapamil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VERAPAMIL HYDROCHLORIDEACTIVE INGREDIENTV3888OEY5RVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
VERAPAMILACTIVE MOIETYCJ0O37KU29VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9790VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 4 package rows20240901_af1249b0-e889-4f02-bdc2-54862de0545e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897649verapamil HCl 240 MG Extended Release Oral TabletPSNaf1249b0-e889-4f02-bdc2-54862de0545e11
897649verapamil hydrochloride 240 MG Extended Release Oral TabletSCDaf1249b0-e889-4f02-bdc2-54862de0545e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-9790-168788979001100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-9790-1) 2012-06-040000-00-00NoNoCurrent
68788-9790-36878897900330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-9790-3) 2012-06-040000-00-00NoNoCurrent
68788-9790-66878897900660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-9790-6) 2012-06-040000-00-00NoNoCurrent
68788-9790-96878897900990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-9790-9) 2012-06-040000-00-00NoNoCurrent