FDA.reportPublic FDA data

verapamil hydrochloride

Product NDC
68462-293
11-digit product format
684620293
Labeler code
68462
Product ID
68462-293_c4ac347e-78cd-490d-9047-73a1df2bd717
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA090700
Marketing category
ANDA
Marketing start
2011-08-05
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
180 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 HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV3888OEY5R
Rxcui897640, 897649, 897659

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
68462-293-01verapamil hydrochloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10011
68462-293-05verapamil hydrochloride500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50011
68462-293-90verapamil hydrochloride90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-293-01EA - Each68462-293a9cddf2a-c529-4c7b-aa73-74376ae6623412012-07-24
68462-293-05EA - Each68462-2939c22ec60-fd88-44a4-b529-e3f149f69a2912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VERAPAMIL HYDROCHLORIDEACTIVE INGREDIENTV3888OEY5RVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
VERAPAMILACTIVE MOIETYCJ0O37KU29VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-293VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]10Current NDC, Legacy NDC, 3 package rows20240104_ba1bf1ae-9347-4d17-998b-14bf7b5984ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897640verapamil HCl 180 MG Extended Release Oral TabletPSNce9ab27a-e03b-4e40-a0e0-b586cd75dead14
897640verapamil hydrochloride 180 MG Extended Release Oral TabletSCDce9ab27a-e03b-4e40-a0e0-b586cd75dead14
897640verapamil HCl 180 MG Extended Release Oral TabletPSN9d529fe3-7b5c-4dde-9a8c-440a969df35913
897640verapamil hydrochloride 180 MG Extended Release Oral TabletSCD9d529fe3-7b5c-4dde-9a8c-440a969df35913
897659verapamil HCl 120 MG Extended Release Oral TabletPSNba1bf1ae-9347-4d17-998b-14bf7b5984ce11
897640verapamil HCl 180 MG Extended Release Oral TabletPSN87f25fef-a8f0-44b2-bc85-3970dad87ebb11
897640verapamil HCl 180 MG Extended Release Oral TabletPSNba1bf1ae-9347-4d17-998b-14bf7b5984ce11
897649verapamil HCl 240 MG Extended Release Oral TabletPSNba1bf1ae-9347-4d17-998b-14bf7b5984ce11
897659verapamil hydrochloride 120 MG Extended Release Oral TabletSCDba1bf1ae-9347-4d17-998b-14bf7b5984ce11
897640verapamil hydrochloride 180 MG Extended Release Oral TabletSCD87f25fef-a8f0-44b2-bc85-3970dad87ebb11
897640verapamil hydrochloride 180 MG Extended Release Oral TabletSCDba1bf1ae-9347-4d17-998b-14bf7b5984ce11
897649verapamil hydrochloride 240 MG Extended Release Oral TabletSCDba1bf1ae-9347-4d17-998b-14bf7b5984ce11
897640verapamil HCl 180 MG Extended Release Oral TabletPSNb800f810-0a23-4eb0-9ef2-da3979e084a58
897649verapamil HCl 240 MG Extended Release Oral TabletPSNb800f810-0a23-4eb0-9ef2-da3979e084a58
897640verapamil hydrochloride 180 MG Extended Release Oral TabletSCDb800f810-0a23-4eb0-9ef2-da3979e084a58
897649verapamil hydrochloride 240 MG Extended Release Oral TabletSCDb800f810-0a23-4eb0-9ef2-da3979e084a58
897640verapamil HCl 180 MG Extended Release Oral TabletPSNf7814f9a-e589-4041-e053-6294a90a29e33
897640verapamil hydrochloride 180 MG Extended Release Oral TabletSCDf7814f9a-e589-4041-e053-6294a90a29e33
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
68462-293-0168462029301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-293-01) 2011-08-050000-00-00NoNoCurrent
68462-293-0568462029305500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-293-05) 2011-08-050000-00-00NoNoCurrent
68462-293-906846202939090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-293-90) 2011-08-050000-00-00NoNoCurrent