Verapamil Hydrochloride

Product NDC
0378-1411
11-digit product format
003781411
Labeler code
0378
Product ID
0378-1411_6ed52e0a-fea3-44ff-b946-a41a76966002
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA074587
Marketing category
ANDA
Marketing start
1996-03-25
Marketing end
0000-00-00
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
240 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1411-01EA - Each0378-1411491adf23-f121-42ba-8404-b9917cf01f3e12012-07-24
0378-1411-05EA - Each0378-14114b2352eb-edca-4386-a538-23f6706def9b12012-07-24
0378-1411-77EA - Each0378-1411075fef8b-911c-4675-9cd3-347d3e80dc7f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VERAPAMIL HYDROCHLORIDEACTIVE INGREDIENTV3888OEY5RVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
VERAPAMILACTIVE MOIETYCJ0O37KU29VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897659verapamil HCl 120 MG Extended Release Oral TabletPSNaf945823-aeae-48b2-97c0-e99e4bd0923f3
897640verapamil HCl 180 MG Extended Release Oral TabletPSNaf945823-aeae-48b2-97c0-e99e4bd0923f3
897649verapamil HCl 240 MG Extended Release Oral TabletPSNaf945823-aeae-48b2-97c0-e99e4bd0923f3
897659verapamil hydrochloride 120 MG Extended Release Oral TabletSCDaf945823-aeae-48b2-97c0-e99e4bd0923f3
897640verapamil hydrochloride 180 MG Extended Release Oral TabletSCDaf945823-aeae-48b2-97c0-e99e4bd0923f3
897649verapamil hydrochloride 240 MG Extended Release Oral TabletSCDaf945823-aeae-48b2-97c0-e99e4bd0923f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-1411-0100378141101100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1411-01) 1996-03-250000-00-00NoNoCurrent
0378-1411-0500378141105500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1411-05) 1996-03-250000-00-00NoNoCurrent
0378-1411-770037814117790 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1411-77) 2009-12-280000-00-00NoNoCurrent