Trandolapril

Product NDC
68258-6100
11-digit product format
682586100
Labeler code
68258
Product ID
68258-6100_67029d98-f499-4123-a1e9-6422f0e72c0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trandolapril
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA077489
Marketing category
ANDA
Marketing start
2007-02-07
Marketing end
0000-00-00
Substance
TRANDOLAPRIL
Active strength
4 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
68258-6100-32019-11-27C16284748780-19855e2a2-3bd6-60a7-e053-dbdaa90a05bdTRANDOLAPRIL TABLETS 7325 7326 7327 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-6100-3Trandolapril30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRANDOLAPRILACTIVE INGREDIENT1T0N3G9CRCTRANDOLAPRIL TABLET [DISPENSING SOLUTIONS, INC.]4
TRANDOLAPRILATACTIVE MOIETYRR6866VL0OTRANDOLAPRIL TABLET [DISPENSING SOLUTIONS, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRANDOLAPRIL TABLET [DISPENSING SOLUTIONS, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRANDOLAPRIL TABLET [DISPENSING SOLUTIONS, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRANDOLAPRIL TABLET [DISPENSING SOLUTIONS, INC.]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XTRANDOLAPRIL TABLET [DISPENSING SOLUTIONS, INC.]4
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UITRANDOLAPRIL TABLET [DISPENSING SOLUTIONS, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRANDOLAPRIL TABLET [DISPENSING SOLUTIONS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-6100TRANDOLAPRIL TABLET [DISPENSING SOLUTIONS, INC.]4Legacy NDC, 1 package rows20131024_ded11cef-9e74-400b-80f4-8947845f5eda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199352trandolapril 4 MG Oral TabletPSNded11cef-9e74-400b-80f4-8947845f5eda4
199352trandolapril 4 MG Oral TabletSCDded11cef-9e74-400b-80f4-8947845f5eda4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-6100-36825861000330 in 1 BOTTLE, PLASTICHistorical