Trandolapril

Product NDC
57237-089
11-digit product format
572370089
Labeler code
57237
Product ID
57237-089_3c365d52-7f5f-477f-8342-4c507b2a7936
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trandolapril
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA078438
Marketing category
ANDA
Marketing start
2007-06-12
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
57237-089-01Trandolapril100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-089-01EA - Each57237-0895ba3ed97-f1b5-4427-8974-6341108bae4e12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRANDOLAPRILACTIVE INGREDIENT1T0N3G9CRCTRANDOLAPRIL TABLET [CITRON PHARMA LLC]2
TRANDOLAPRILATACTIVE MOIETYRR6866VL0OTRANDOLAPRIL TABLET [CITRON PHARMA LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TRANDOLAPRIL TABLET [CITRON PHARMA LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRANDOLAPRIL TABLET [CITRON PHARMA LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRANDOLAPRIL TABLET [CITRON PHARMA LLC]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TRANDOLAPRIL TABLET [CITRON PHARMA LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRANDOLAPRIL TABLET [CITRON PHARMA LLC]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XTRANDOLAPRIL TABLET [CITRON PHARMA LLC]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UITRANDOLAPRIL TABLET [CITRON PHARMA LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRANDOLAPRIL TABLET [CITRON PHARMA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-089TRANDOLAPRIL TABLET [RISING PHARMA HOLDINGS, INC.]7Current NDC, Legacy NDC, 1 package rows20240424_0107d19a-b43a-4a36-8b8c-4dfc247630e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199353trandolapril 1 MG Oral TabletPSN0107d19a-b43a-4a36-8b8c-4dfc247630e97
199351trandolapril 2 MG Oral TabletPSN0107d19a-b43a-4a36-8b8c-4dfc247630e97
199352trandolapril 4 MG Oral TabletPSN0107d19a-b43a-4a36-8b8c-4dfc247630e97
199353trandolapril 1 MG Oral TabletSCD0107d19a-b43a-4a36-8b8c-4dfc247630e97
199351trandolapril 2 MG Oral TabletSCD0107d19a-b43a-4a36-8b8c-4dfc247630e97
199352trandolapril 4 MG Oral TabletSCD0107d19a-b43a-4a36-8b8c-4dfc247630e97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-089-0157237008901100 TABLET in 1 BOTTLE (57237-089-01) 100 tablet2007-06-120000-00-00NoNoCurrent