FDA.reportPublic FDA data

Trandolapril and Verapamil Hydrochloride

Product NDC
68462-329
11-digit product format
684620329
Labeler code
68462
Product ID
68462-329_770b4914-a475-4841-83f8-79261f115eff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trandolapril and Verapamil Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA079135
Marketing category
ANDA
Marketing start
2015-02-25
Substance
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
Active strength
4; 240 mg/1; mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trandolapril and Verapamil Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRANDOLAPRIL4 mg/1
VERAPAMIL HYDROCHLORIDE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1T0N3G9CRC, V3888OEY5R
Rxcui897781, 897783, 897844, 897853

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
980ce3cc-8943-91ef-56b2-a0bae7a2b9f9Product name120140508
d3b67bc2-0e96-e3ec-06a9-90afcc07bf13Product name120140508
e2fcd66c-a043-3187-790d-b0342deb1149Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-329-01Trandolapril and Verapamil Hydrochloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10013
68462-329-10Trandolapril and Verapamil Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-329-01EA - Each68462-329e5272f0a-1f44-4c7c-aa85-a07d7fa88ad812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRANDOLAPRILACTIVE INGREDIENT1T0N3G9CRCTRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
VERAPAMIL HYDROCHLORIDEACTIVE INGREDIENTV3888OEY5RTRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
TRANDOLAPRILATACTIVE MOIETYRR6866VL0OTRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
VERAPAMILACTIVE MOIETYCJ0O37KU29TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
POVIDONESINACTIVE INGREDIENTFZ989GH94ETRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQTRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UITRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-329TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]12Current NDC, Legacy NDC, 2 package rows20240104_39bad727-af4c-4d20-933b-7f287e88099a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897781trandolapril 1 MG / verapamil HCl 240 MG 24HR Extended Release Oral TabletPSN39bad727-af4c-4d20-933b-7f287e88099a13
897783trandolapril 2 MG / verapamil HCl 180 MG 24HR Extended Release Oral TabletPSN39bad727-af4c-4d20-933b-7f287e88099a13
897844trandolapril 2 MG / verapamil HCl 240 MG 24HR Extended Release Oral TabletPSN39bad727-af4c-4d20-933b-7f287e88099a13
897853trandolapril 4 MG / verapamil HCl 240 MG 24HR Extended Release Oral TabletPSN39bad727-af4c-4d20-933b-7f287e88099a13
89778124 HR trandolapril 1 MG / verapamil hydrochloride 240 MG Extended Release Oral TabletSCD39bad727-af4c-4d20-933b-7f287e88099a13
89778324 HR trandolapril 2 MG / verapamil hydrochloride 180 MG Extended Release Oral TabletSCD39bad727-af4c-4d20-933b-7f287e88099a13
89784424 HR trandolapril 2 MG / verapamil hydrochloride 240 MG Extended Release Oral TabletSCD39bad727-af4c-4d20-933b-7f287e88099a13
89785324 HR trandolapril 4 MG / verapamil hydrochloride 240 MG Extended Release Oral TabletSCD39bad727-af4c-4d20-933b-7f287e88099a13
897781trandolapril 1 MG / verapamil hydrochloride 240 MG 24 HR Extended Release Oral TabletSY39bad727-af4c-4d20-933b-7f287e88099a13
897783trandolapril 2 MG / verapamil hydrochloride 180 MG 24 HR Extended Release Oral TabletSY39bad727-af4c-4d20-933b-7f287e88099a13
897844trandolapril 2 MG / verapamil hydrochloride 240 MG 24 HR Extended Release Oral TabletSY39bad727-af4c-4d20-933b-7f287e88099a13
897853trandolapril 4 MG / verapamil hydrochloride 240 MG 24 HR Extended Release Oral TabletSY39bad727-af4c-4d20-933b-7f287e88099a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-329-0168462032901100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-329-01) 2015-02-250000-00-00NoNoCurrent
68462-329-10684620329101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-329-10) 2015-02-250000-00-00NoNoCurrent