FDA.reportPublic FDA data

Trandolapril

Product NDC
68180-566
11-digit product format
681800566
Labeler code
68180
Product ID
68180-566_97cefaf3-9c1f-43e3-a30c-e9631872a8e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trandolapril
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA077522
Marketing category
ANDA
Marketing start
2007-06-11
Substance
TRANDOLAPRIL
Active strength
1 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
TRANDOLAPRIL1 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
68180-566-01Trandolapril100 in 1 BOTTLETABLET10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-566-01EA - Each68180-5663ae7ad7e-59e5-422e-a49f-ec6fda71ffe112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRANDOLAPRILACTIVE INGREDIENT1T0N3G9CRCTRANDOLAPRIL TABLET [LUPIN PHARMACEUTICALS, INC.]5
TRANDOLAPRILATACTIVE MOIETYRR6866VL0OTRANDOLAPRIL TABLET [LUPIN PHARMACEUTICALS, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TRANDOLAPRIL TABLET [LUPIN PHARMACEUTICALS, INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRANDOLAPRIL TABLET [LUPIN PHARMACEUTICALS, INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRANDOLAPRIL TABLET [LUPIN PHARMACEUTICALS, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRANDOLAPRIL TABLET [LUPIN PHARMACEUTICALS, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRANDOLAPRIL TABLET [LUPIN PHARMACEUTICALS, INC.]5
POVIDONEINACTIVE INGREDIENTFZ989GH94ETRANDOLAPRIL TABLET [LUPIN PHARMACEUTICALS, INC.]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UITRANDOLAPRIL TABLET [LUPIN PHARMACEUTICALS, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRANDOLAPRIL TABLET [LUPIN PHARMACEUTICALS, INC.]5
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
68180-566TRANDOLAPRIL TABLET [LUPIN PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 1 package rows20211210_8143a6cf-dadc-4ef7-a8db-d16d7150ad34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199353trandolapril 1 MG Oral TabletPSN8143a6cf-dadc-4ef7-a8db-d16d7150ad3413
199351trandolapril 2 MG Oral TabletPSN8143a6cf-dadc-4ef7-a8db-d16d7150ad3413
199352trandolapril 4 MG Oral TabletPSN8143a6cf-dadc-4ef7-a8db-d16d7150ad3413
199353trandolapril 1 MG Oral TabletSCD8143a6cf-dadc-4ef7-a8db-d16d7150ad3413
199351trandolapril 2 MG Oral TabletSCD8143a6cf-dadc-4ef7-a8db-d16d7150ad3413
199352trandolapril 4 MG Oral TabletSCD8143a6cf-dadc-4ef7-a8db-d16d7150ad3413
199353trandolapril 1 MG Oral TabletPSN94de983f-549b-42ed-9f40-b022aa3bef0f4
199353trandolapril 1 MG Oral TabletPSN9b6b2156-7f20-47a1-80e5-e0db3188769e4
199353trandolapril 1 MG Oral TabletSCD94de983f-549b-42ed-9f40-b022aa3bef0f4
199353trandolapril 1 MG Oral TabletSCD9b6b2156-7f20-47a1-80e5-e0db3188769e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-566-0168180056601100 TABLET in 1 BOTTLE (68180-566-01) 100 tablet2007-06-110000-00-00NoNoCurrent