FDA.reportPublic FDA data

Trandolapril

Product NDC
63629-8003
11-digit product format
636298003
Labeler code
63629
Product ID
63629-8003_6393820e-daaa-41b2-b2cb-5fe6c433a854
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trandolapril
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

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
63629-8003-12025-09-05C16284748780-11030e365-4174-111a-e063-dadaa90a10e2TRANDOLAPRIL TABLETS Rx only
63629-8003-22025-09-05C16284748780-11030e365-4174-111a-e063-dadaa90a10e2TRANDOLAPRIL TABLETS Rx only
63629-8003-12024-01-30C16284748780-11030e365-4174-111a-e063-dadaa90a10e2TRANDOLAPRIL TABLETS Rx only
63629-8003-22024-01-30C16284748780-11030e365-4174-111a-e063-dadaa90a10e2TRANDOLAPRIL TABLETS Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8003-1Trandolapril30 in 1 BOTTLETABLET305
63629-8003-2Trandolapril90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8003TRANDOLAPRIL TABLET [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 2 package rows20220217_514f53e6-ff6b-4d02-9db9-2575b15aa5f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
63629-8003-16362980030130 TABLET in 1 BOTTLE (63629-8003-1) 30 tablet2019-05-020000-00-00NoNoCurrent
63629-8003-26362980030290 TABLET in 1 BOTTLE (63629-8003-2) 90 tablet2022-02-090000-00-00NoNoCurrent