FDA.reportPublic FDA data

Trandolapril

Product NDC
42806-054
11-digit product format
428060054
Labeler code
42806
Product ID
42806-054_71e96bed-1a18-49d6-e053-2995a90a3014
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trandolapril Tablets
Dosage form
TABLET
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA078508
Marketing category
ANDA
Marketing start
2015-03-31
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078508-001TRANDOLAPRILTRANDOLAPRIL2MGTABLET / ORALAB2008-06-18
A078508-002TRANDOLAPRILTRANDOLAPRIL4MGTABLET / ORALAB2008-06-18
A078508-003TRANDOLAPRILTRANDOLAPRIL1MGTABLET / ORALAB2008-06-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078508-001AB
A078508-002AB
A078508-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078508-001TRANDOLAPRIL2MGTABLET / ORALAB2008-06-18a50c72e98297…
2026-08-01 22:54:322026-06A078508-002TRANDOLAPRIL4MGTABLET / ORALAB2008-06-18a50c72e98297…
2026-08-01 22:54:322026-06A078508-003TRANDOLAPRIL1MGTABLET / ORALAB2008-06-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078508-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078508-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078508-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrandolaprilTRANDOLAPRIL TABLETSEpic Pharma, LLC10f25119-9970-46fe-bf36-6fec6064895b2018-07-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078508
application number: ANDA078508
ndc (product): 42806-054

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1T0N3G9CRCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199351Internal RxNorm lookup
199352Internal RxNorm lookup
199353Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
10f25119-9970-46fe-bf36-6fec6064895bAvailable on FDA.report

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
42806-054-01Trandolapril100 in 1 BOTTLETABLET1008
42806-054-10Trandolapril1000 in 1 BOTTLETABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-054-01EA - Each42806-054b7555cf5-d1a2-43e8-9fa7-653b7727b4be12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRANDOLAPRILACTIVE INGREDIENT1T0N3G9CRCTRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC]4
TRANDOLAPRILATACTIVE MOIETYRR6866VL0OTRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC]4
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KTRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XTRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC]4
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UITRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-054TRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC]8Current NDC, Legacy NDC, 2 package rows20180726_10f25119-9970-46fe-bf36-6fec6064895b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199353trandolapril 1 MG Oral TabletPSN10f25119-9970-46fe-bf36-6fec6064895b8
199351trandolapril 2 MG Oral TabletPSN10f25119-9970-46fe-bf36-6fec6064895b8
199352trandolapril 4 MG Oral TabletPSN10f25119-9970-46fe-bf36-6fec6064895b8
199353trandolapril 1 MG Oral TabletSCD10f25119-9970-46fe-bf36-6fec6064895b8
199351trandolapril 2 MG Oral TabletSCD10f25119-9970-46fe-bf36-6fec6064895b8
199352trandolapril 4 MG Oral TabletSCD10f25119-9970-46fe-bf36-6fec6064895b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-054-0142806005401100 TABLET in 1 BOTTLE (42806-054-01) 100 tablet2015-03-310000-00-00NoNoCurrent
42806-054-10428060054101000 TABLET in 1 BOTTLE (42806-054-10) 1000 tablet2015-03-310000-00-00NoNoCurrent