Trandolapril

Product NDC
68180-567
11-digit product format
681800567
Labeler code
68180
Product ID
68180-567_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
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
68180-567-01Trandolapril100 in 1 BOTTLETABLET10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-567-01EA - Each68180-5679b56c0e4-4521-4ac9-ba3c-36465b53610212012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-567TRANDOLAPRIL 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
199351trandolapril 2 MG Oral TabletPSN514f53e6-ff6b-4d02-9db9-2575b15aa5f05
199351trandolapril 2 MG Oral TabletSCD514f53e6-ff6b-4d02-9db9-2575b15aa5f05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-567-0168180056701100 TABLET in 1 BOTTLE (68180-567-01) 100 tablet2007-06-110000-00-00NoNoCurrent