FDA.reportPublic FDA data

Trandolapril

Product NDC
68151-0757
11-digit product format
681510757
Labeler code
68151
Product ID
68151-0757_942126ae-9a8e-4261-8c1b-f1403873547a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trandolapril
Dosage form
TABLET
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA077522
Marketing category
ANDA
Marketing start
2007-06-11
Marketing end
0000-00-00
Substance
TRANDOLAPRIL
Active strength
1 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-0757-02020-01-31C16284748780-19d75b9d0-077e-f424-e053-dadaa90a57ceTRANDOLAPRIL TABLETS Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-0757-0Trandolapril1 in 1 PACKAGETABLET14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRANDOLAPRILACTIVE INGREDIENT1T0N3G9CRCTRANDOLAPRIL TABLET [CARILION MATERIALS MANAGEMENT]2
TRANDOLAPRILATACTIVE MOIETYRR6866VL0OTRANDOLAPRIL TABLET [CARILION MATERIALS MANAGEMENT]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TRANDOLAPRIL TABLET [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRANDOLAPRIL TABLET [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRANDOLAPRIL TABLET [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRANDOLAPRIL TABLET [CARILION MATERIALS MANAGEMENT]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ETRANDOLAPRIL TABLET [CARILION MATERIALS MANAGEMENT]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UITRANDOLAPRIL TABLET [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRANDOLAPRIL TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-0757TRANDOLAPRIL TABLET [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20170706_94de983f-549b-42ed-9f40-b022aa3bef0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199353trandolapril 1 MG Oral TabletPSN94de983f-549b-42ed-9f40-b022aa3bef0f4
199353trandolapril 1 MG Oral TabletSCD94de983f-549b-42ed-9f40-b022aa3bef0f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-0757-0681510757001 in 1 PACKAGEHistorical