FDA.reportPublic FDA data

Tarka

Product NDC
0074-3290
11-digit product format
000743290
Labeler code
0074
Product ID
0074-3290_f9fce1b1-4300-ab41-7107-8328a4b01c60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trandolapril and Verapamil Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
AbbVie Inc.
Application
NDA020591
Marketing category
NDA
Marketing start
1996-10-22
Marketing end
2021-08-18
Substance
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
Active strength
4 mg/1; mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],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
0000-00-00
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
980ce3cc-8943-91ef-56b2-a0bae7a2b9f9Product 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
0074-3290-13EA - Each0074-32902f9466a6-52cd-48c4-9a13-f0b3f29f68a812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
trandolaprilACTIVE INGREDIENT1T0N3G9CRCTARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
verapamil hydrochlorideACTIVE INGREDIENTV3888OEY5RTARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
trandolaprilACTIVE MOIETY1T0N3G9CRCTARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
verapamilACTIVE MOIETYCJ0O37KU29TARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MTARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0TARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PTARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
lactoseINACTIVE INGREDIENTJ2B2A4N98GTARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30TARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ATARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
povidoneINACTIVE INGREDIENTFZ989GH94ETARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
sodium alginateINACTIVE INGREDIENTC269C4G2ZQTARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
sodium stearyl fumarateINACTIVE INGREDIENT7CV7WJK4UITARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UTARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RTARKA (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897785Tarka 2 MG / 180 MG 24HR Extended Release Oral TabletPSN3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
897846Tarka 2 MG / 240 MG 24HR Extended Release Oral TabletPSN3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
897855Tarka 4 MG / 240 MG 24HR Extended Release Oral TabletPSN3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
897783trandolapril 2 MG / verapamil HCl 180 MG 24HR Extended Release Oral TabletPSN3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
897844trandolapril 2 MG / verapamil HCl 240 MG 24HR Extended Release Oral TabletPSN3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
897853trandolapril 4 MG / verapamil HCl 240 MG 24HR Extended Release Oral TabletPSN3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
89778524 HR trandolapril 2 MG / verapamil hydrochloride 180 MG Extended Release Oral Tablet [Tarka]SBD3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
89784624 HR trandolapril 2 MG / verapamil hydrochloride 240 MG Extended Release Oral Tablet [Tarka]SBD3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
89785524 HR trandolapril 4 MG / verapamil hydrochloride 240 MG Extended Release Oral Tablet [Tarka]SBD3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
89778324 HR trandolapril 2 MG / verapamil hydrochloride 180 MG Extended Release Oral TabletSCD3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
89784424 HR trandolapril 2 MG / verapamil hydrochloride 240 MG Extended Release Oral TabletSCD3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
89785324 HR trandolapril 4 MG / verapamil hydrochloride 240 MG Extended Release Oral TabletSCD3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
897785Tarka 2/180 (trandolapril / verapamil hydrochloride) 24 HR Extended Release Oral TabletSY3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
897785Tarka 2/180 24 HR Extended Release Oral TabletSY3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
897846Tarka 2/240 (trandolapril / verapamil hydrochloride) 24 HR Extended Release Oral TabletSY3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
897846Tarka 2/240 24 HR Extended Release Oral TabletSY3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
897855Tarka 4/240 (trandolapril / verapamil hydrochloride) 24 HR Extended Release Oral TabletSY3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
897855Tarka 4/240 24 HR Extended Release Oral TabletSY3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
897783trandolapril 2 MG / verapamil hydrochloride 180 MG 24 HR Extended Release Oral TabletSY3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
897844trandolapril 2 MG / verapamil hydrochloride 240 MG 24 HR Extended Release Oral TabletSY3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92
897853trandolapril 4 MG / verapamil hydrochloride 240 MG 24 HR Extended Release Oral TabletSY3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0074-3290-1300074329013100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3290-13) 1996-10-222021-08-18NoNoCurrent