Trandolapril

Product NDC
65862-166
11-digit product format
658620166
Labeler code
65862
Product ID
65862-166_004262f3-c8d0-43c9-a760-641c22748858
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trandolapril
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078438
Marketing category
ANDA
Marketing start
2007-06-12
Substance
TRANDOLAPRIL
Active strength
4 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
TRANDOLAPRIL4 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
65862-166-01Trandolapril100 in 1 BOTTLETABLET10019
65862-166-99Trandolapril1000 in 1 BOTTLETABLET100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-166-01EA - Each65862-1664c7967f7-c4c4-44da-99d3-a0845b6c756f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRANDOLAPRILACTIVE INGREDIENT1T0N3G9CRCTRANDOLAPRIL TABLET [AUROBINDO PHARMA LIMITED]14
TRANDOLAPRILATACTIVE MOIETYRR6866VL0OTRANDOLAPRIL TABLET [AUROBINDO PHARMA LIMITED]14
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TRANDOLAPRIL TABLET [AUROBINDO PHARMA LIMITED]14
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRANDOLAPRIL TABLET [AUROBINDO PHARMA LIMITED]14
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRANDOLAPRIL TABLET [AUROBINDO PHARMA LIMITED]14
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TRANDOLAPRIL TABLET [AUROBINDO PHARMA LIMITED]14
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRANDOLAPRIL TABLET [AUROBINDO PHARMA LIMITED]14
POVIDONE K30INACTIVE INGREDIENTU725QWY32XTRANDOLAPRIL TABLET [AUROBINDO PHARMA LIMITED]14
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UITRANDOLAPRIL TABLET [AUROBINDO PHARMA LIMITED]14
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRANDOLAPRIL TABLET [AUROBINDO PHARMA LIMITED]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-166TRANDOLAPRIL TABLET [AUROBINDO PHARMA LIMITED]19Current NDC, Legacy NDC, 2 package rows20240421_6f25ed16-e5e9-4170-b4b4-3b460887779e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199353trandolapril 1 MG Oral TabletPSN6f25ed16-e5e9-4170-b4b4-3b460887779e19
199351trandolapril 2 MG Oral TabletPSN6f25ed16-e5e9-4170-b4b4-3b460887779e19
199352trandolapril 4 MG Oral TabletPSN6f25ed16-e5e9-4170-b4b4-3b460887779e19
199353trandolapril 1 MG Oral TabletSCD6f25ed16-e5e9-4170-b4b4-3b460887779e19
199351trandolapril 2 MG Oral TabletSCD6f25ed16-e5e9-4170-b4b4-3b460887779e19
199352trandolapril 4 MG Oral TabletSCD6f25ed16-e5e9-4170-b4b4-3b460887779e19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-166-0165862016601100 TABLET in 1 BOTTLE (65862-166-01) 100 tablet2007-06-120000-00-00NoNoCurrent
65862-166-99658620166991000 TABLET in 1 BOTTLE (65862-166-99) 1000 tablet2007-06-120000-00-00NoNoCurrent