Trandolapril

Product NDC
65862-164
Requested package NDC
65862-164-53
11-digit product format
658620164
Labeler code
65862
Product ID
65862-164_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
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage65862-16465862-164-53UNFINISHEDActive or certified unfinished drug listing2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-174184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-104bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-305b2001dcd8f5…54b53d4dc9e4…

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
A078438-001TRANDOLAPRILTRANDOLAPRIL1MGTABLET / ORALAB2007-06-12
A078438-002TRANDOLAPRILTRANDOLAPRIL2MGTABLET / ORALAB2007-06-12
A078438-003TRANDOLAPRILTRANDOLAPRIL4MGTABLET / ORALAB2007-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078438-001AB
A078438-002AB
A078438-003AB

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078438-001TRANDOLAPRIL1MGTABLET / ORALAB2007-06-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078438-002TRANDOLAPRIL2MGTABLET / ORALAB2007-06-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078438-003TRANDOLAPRIL4MGTABLET / ORALAB2007-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078438-001TRANDOLAPRIL1MGTABLET / ORALAB2007-06-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078438-002TRANDOLAPRIL2MGTABLET / ORALAB2007-06-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078438-003TRANDOLAPRIL4MGTABLET / ORALAB2007-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078438-001TRANDOLAPRIL1MGTABLET / ORALAB2007-06-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078438-002TRANDOLAPRIL2MGTABLET / ORALAB2007-06-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078438-003TRANDOLAPRIL4MGTABLET / ORALAB2007-06-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078438-001TRANDOLAPRIL1MGTABLET / ORALAB2007-06-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078438-002TRANDOLAPRIL2MGTABLET / ORALAB2007-06-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078438-003TRANDOLAPRIL4MGTABLET / ORALAB2007-06-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078438-001TRANDOLAPRIL1MGTABLET / ORALAB2007-06-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078438-002TRANDOLAPRIL2MGTABLET / ORALAB2007-06-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078438-003TRANDOLAPRIL4MGTABLET / ORALAB2007-06-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078438-001TRANDOLAPRIL1MGTABLET / ORALAB2007-06-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078438-002TRANDOLAPRIL2MGTABLET / ORALAB2007-06-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078438-003TRANDOLAPRIL4MGTABLET / ORALAB2007-06-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078438-001TRANDOLAPRIL1MGTABLET / ORALAB2007-06-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078438-002TRANDOLAPRIL2MGTABLET / ORALAB2007-06-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078438-003TRANDOLAPRIL4MGTABLET / ORALAB2007-06-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078438-001TRANDOLAPRIL1MGTABLET / ORALAB2007-06-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078438-002TRANDOLAPRIL2MGTABLET / ORALAB2007-06-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078438-003TRANDOLAPRIL4MGTABLET / ORALAB2007-06-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078438-001TRANDOLAPRIL1MGTABLET / ORALAB2007-06-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078438-002TRANDOLAPRIL2MGTABLET / ORALAB2007-06-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078438-003TRANDOLAPRIL4MGTABLET / ORALAB2007-06-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078438-001TRANDOLAPRIL1MGTABLET / ORALAB2007-06-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A078438-002TRANDOLAPRIL2MGTABLET / ORALAB2007-06-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A078438-003TRANDOLAPRIL4MGTABLET / ORALAB2007-06-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078438-001TRANDOLAPRIL1MGTABLET / ORALAB2007-06-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078438-002TRANDOLAPRIL2MGTABLET / ORALAB2007-06-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078438-003TRANDOLAPRIL4MGTABLET / ORALAB2007-06-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078438-001TRANDOLAPRIL1MGTABLET / ORALAB2007-06-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078438-002TRANDOLAPRIL2MGTABLET / ORALAB2007-06-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078438-003TRANDOLAPRIL4MGTABLET / ORALAB2007-06-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078438-001TRANDOLAPRIL1MGTABLET / ORALAB2007-06-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078438-002TRANDOLAPRIL2MGTABLET / ORALAB2007-06-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078438-003TRANDOLAPRIL4MGTABLET / ORALAB2007-06-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078438-001TRANDOLAPRIL1MGTABLET / ORALAB2007-06-128072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078438-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078438-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078438-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078438-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078438-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078438-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078438-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078438-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078438-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078438-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078438-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078438-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078438-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078438-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078438-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078438-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078438-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078438-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078438-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078438-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078438-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078438-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078438-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078438-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078438-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078438-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078438-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078438-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078438-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078438-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078438-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078438-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078438-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078438-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078438-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078438-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078438-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078438-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078438-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078438-001AB18072bd15b7f6…

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 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
6f25ed16-e5e9-4170-b4b4-3b460887779eAvailable 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
65862-164-01Trandolapril100 in 1 BOTTLETABLET10019
65862-164-99Trandolapril1000 in 1 BOTTLETABLET100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-164-01EA - Each65862-164719ca0e6-3db3-412d-aaba-d29ec537776412012-07-24

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
65862-164TRANDOLAPRIL TABLET [AUROBINDO PHARMA LIMITED]19Current NDC, Legacy NDC, 2 package rows20240421_6f25ed16-e5e9-4170-b4b4-3b460887779e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrandolaprilTRANDOLAPRILBryant Ranch Prepack57f8aac6-3bd3-4ae1-aab2-759c8bc232922024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078438
application number: ANDA078438
TrandolaprilTRANDOLAPRILAurobindo Pharma Limited6f25ed16-e5e9-4170-b4b4-3b460887779e2024-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078438
application number: ANDA078438
ndc (product): 65862-164
TrandolaprilTRANDOLAPRILRising Pharma Holdings, Inc.0107d19a-b43a-4a36-8b8c-4dfc247630e92024-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078438
application number: ANDA078438

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 startStatus
65862-164-536586201645312000 TABLET in 1 BAG (65862-164-53)12000 tablet12-JUN-07Current