Trandolapril

Product NDC
42806-053
11-digit product format
428060053
Labeler code
42806
Product ID
42806-053_71e96bed-1a18-49d6-e053-2995a90a3014
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trandolapril Tablets
Dosage form
TABLET
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA078508
Marketing category
ANDA
Marketing start
2015-03-31
Substance
TRANDOLAPRIL
Active strength
2 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme 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
Trandolapril
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRANDOLAPRIL2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1T0N3G9CRC
Rxcui199351, 199352, 199353

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
980ce3cc-8943-91ef-56b2-a0bae7a2b9f9Product name120140508
d3b67bc2-0e96-e3ec-06a9-90afcc07bf13Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-053-01Trandolapril100 in 1 BOTTLETABLET1008
42806-053-10Trandolapril1000 in 1 BOTTLETABLET10008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-053TRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC]8Current NDC, Legacy NDC, 2 package rows20180726_10f25119-9970-46fe-bf36-6fec6064895b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199353trandolapril 1 MG Oral TabletPSN10f25119-9970-46fe-bf36-6fec6064895b8
199351trandolapril 2 MG Oral TabletPSN10f25119-9970-46fe-bf36-6fec6064895b8
199352trandolapril 4 MG Oral TabletPSN10f25119-9970-46fe-bf36-6fec6064895b8
199353trandolapril 1 MG Oral TabletSCD10f25119-9970-46fe-bf36-6fec6064895b8
199351trandolapril 2 MG Oral TabletSCD10f25119-9970-46fe-bf36-6fec6064895b8
199352trandolapril 4 MG Oral TabletSCD10f25119-9970-46fe-bf36-6fec6064895b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-053-0142806005301100 TABLET in 1 BOTTLE (42806-053-01) 100 tablet2015-03-310000-00-00NoNoCurrent
42806-053-10428060053101000 TABLET in 1 BOTTLE (42806-053-10) 1000 tablet2015-03-310000-00-00NoNoCurrent