Perindopril Erbumine

Product NDC
65862-286
11-digit product format
658620286
Labeler code
65862
Product ID
65862-286_46f1c769-2a77-4526-8303-0abc4a78d53e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Perindopril Erbumine
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA079070
Marketing category
ANDA
Marketing start
2009-11-10
Substance
PERINDOPRIL ERBUMINE
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct65862-286UNFINISHEDActive or certified unfinished drug listing2026-10-05
unfinished packagepackage65862-28665862-286-53UNFINISHEDActive or certified unfinished drug listing2026-10-05

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 · 40 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-286-53a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-286-531d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-286-53390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-286-53e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-286-53bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-286-53f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-286-53f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-286-5368b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-286-5305c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-286-5348b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-286-5327f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-286-538d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-286-53d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-286-5350b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-286-53906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-286-536db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-286-538fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-286-534184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-286-534bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-286-53263afe128892…91768de4ddbe…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A079070-001PERINDOPRIL ERBUMINEPERINDOPRIL ERBUMINE2MGTABLET / ORAL2009-11-10
A079070-002PERINDOPRIL ERBUMINEPERINDOPRIL ERBUMINE4MGTABLET / ORAL2009-11-10
A079070-003PERINDOPRIL ERBUMINEPERINDOPRIL ERBUMINE8MGTABLET / ORALRS2009-11-10

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A079070-001PERINDOPRIL ERBUMINE2MGTABLET / ORAL2009-11-1084e616aacf4f…
2026-09-14 22:38:342026-08A079070-002PERINDOPRIL ERBUMINE4MGTABLET / ORAL2009-11-1084e616aacf4f…
2026-09-14 22:38:342026-08A079070-003PERINDOPRIL ERBUMINE8MGTABLET / ORALRS2009-11-1084e616aacf4f…
2026-08-18 06:07:402026-07A079070-001PERINDOPRIL ERBUMINE2MGTABLET / ORAL2009-11-10caaa826d4ba7…
2026-08-18 06:07:402026-07A079070-002PERINDOPRIL ERBUMINE4MGTABLET / ORAL2009-11-10caaa826d4ba7…
2026-08-18 06:07:402026-07A079070-003PERINDOPRIL ERBUMINE8MGTABLET / ORALRS2009-11-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079070-001PERINDOPRIL ERBUMINE2MGTABLET / ORAL2009-11-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079070-002PERINDOPRIL ERBUMINE4MGTABLET / ORAL2009-11-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079070-003PERINDOPRIL ERBUMINE8MGTABLET / ORALRS2009-11-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079070-001PERINDOPRIL ERBUMINE2MGTABLET / ORAL2009-11-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079070-002PERINDOPRIL ERBUMINE4MGTABLET / ORAL2009-11-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079070-003PERINDOPRIL ERBUMINE8MGTABLET / ORALRS2009-11-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A079070-001PERINDOPRIL ERBUMINE2MGTABLET / ORAL2009-11-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079070-002PERINDOPRIL ERBUMINE4MGTABLET / ORAL2009-11-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079070-003PERINDOPRIL ERBUMINE8MGTABLET / ORALRS2009-11-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079070-001PERINDOPRIL ERBUMINE2MGTABLET / ORAL2009-11-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079070-002PERINDOPRIL ERBUMINE4MGTABLET / ORAL2009-11-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079070-003PERINDOPRIL ERBUMINE8MGTABLET / ORALRS2009-11-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079070-001PERINDOPRIL ERBUMINE2MGTABLET / ORAL2009-11-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079070-002PERINDOPRIL ERBUMINE4MGTABLET / ORAL2009-11-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079070-003PERINDOPRIL ERBUMINE8MGTABLET / ORALRS2009-11-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079070-001PERINDOPRIL ERBUMINE2MGTABLET / ORAL2009-11-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079070-002PERINDOPRIL ERBUMINE4MGTABLET / ORAL2009-11-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079070-003PERINDOPRIL ERBUMINE8MGTABLET / ORALRS2009-11-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079070-001PERINDOPRIL ERBUMINE2MGTABLET / ORAL2009-11-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079070-002PERINDOPRIL ERBUMINE4MGTABLET / ORAL2009-11-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079070-003PERINDOPRIL ERBUMINE8MGTABLET / ORALRS2009-11-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079070-001PERINDOPRIL ERBUMINE2MGTABLET / ORAL2009-11-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079070-002PERINDOPRIL ERBUMINE4MGTABLET / ORAL2009-11-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079070-003PERINDOPRIL ERBUMINE8MGTABLET / ORALRS2009-11-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079070-001PERINDOPRIL ERBUMINE2MGTABLET / ORAL2009-11-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079070-002PERINDOPRIL ERBUMINE4MGTABLET / ORAL2009-11-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079070-003PERINDOPRIL ERBUMINE8MGTABLET / ORALRS2009-11-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079070-001PERINDOPRIL ERBUMINE2MGTABLET / ORAL2009-11-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A079070-002PERINDOPRIL ERBUMINE4MGTABLET / ORAL2009-11-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A079070-003PERINDOPRIL ERBUMINE8MGTABLET / ORALRS2009-11-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079070-001PERINDOPRIL ERBUMINE2MGTABLET / ORAL2009-11-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079070-002PERINDOPRIL ERBUMINE4MGTABLET / ORAL2009-11-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079070-003PERINDOPRIL ERBUMINE8MGTABLET / ORALRS2009-11-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079070-001PERINDOPRIL ERBUMINE2MGTABLET / ORAL2009-11-10301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079070-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079070-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079070-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079070-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079070-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079070-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079070-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079070-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079070-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079070-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079070-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079070-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079070-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A079070-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A079070-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079070-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A079070-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A079070-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079070-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079070-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079070-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A079070-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A079070-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A079070-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079070-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A079070-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A079070-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079070-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A079070-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A079070-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079070-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A079070-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A079070-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A079070-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A079070-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A079070-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A079070-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A079070-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A079070-003AB1ea99ee380514…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079070-003AB13a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Perindopril Erbumine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PERINDOPRIL ERBUMINE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1964X464OJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
854925Internal RxNorm lookup
854984Internal RxNorm lookup
854988Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
87768fbf-7c63-47da-8925-0316f343d6efAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
b7225d76-59fc-c13f-c287-78d1c893ca87Product name220150206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-286-01Perindopril Erbumine100 in 1 BOTTLETABLET10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-286-01EA - Each65862-28676f612b1-37e2-4a2f-b87c-1989f5346c0f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PERINDOPRIL ERBUMINEACTIVE INGREDIENT1964X464OJPERINDOPRIL ERBUMINE TABLET [AUROBINDO PHARMA LIMITED]8
PERINDOPRILATACTIVE MOIETY2UV6ZNQ92KPERINDOPRIL ERBUMINE TABLET [AUROBINDO PHARMA LIMITED]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPERINDOPRIL ERBUMINE TABLET [AUROBINDO PHARMA LIMITED]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPERINDOPRIL ERBUMINE TABLET [AUROBINDO PHARMA LIMITED]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PERINDOPRIL ERBUMINE TABLET [AUROBINDO PHARMA LIMITED]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PERINDOPRIL ERBUMINE TABLET [AUROBINDO PHARMA LIMITED]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-286PERINDOPRIL ERBUMINE TABLET [AUROBINDO PHARMA LIMITED]17Current NDC, Legacy NDC, 1 package rows20240319_87768fbf-7c63-47da-8925-0316f343d6ef.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perindopril ErbuminePERINDOPRIL ERBUMINEAurobindo Pharma Limited87768fbf-7c63-47da-8925-0316f343d6ef2024-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079070
application number: ANDA079070
ndc (product): 65862-286

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854984perindopril erbumine 2 MG Oral TabletPSN87768fbf-7c63-47da-8925-0316f343d6ef17
854988perindopril erbumine 4 MG Oral TabletPSN87768fbf-7c63-47da-8925-0316f343d6ef17
854925perindopril erbumine 8 MG Oral TabletPSN87768fbf-7c63-47da-8925-0316f343d6ef17
854984perindopril erbumine 2 MG Oral TabletSCD87768fbf-7c63-47da-8925-0316f343d6ef17
854988perindopril erbumine 4 MG Oral TabletSCD87768fbf-7c63-47da-8925-0316f343d6ef17
854925perindopril erbumine 8 MG Oral TabletSCD87768fbf-7c63-47da-8925-0316f343d6ef17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-286-0165862028601100 TABLET in 1 BOTTLE (65862-286-01) 100 tablet2009-11-100000-00-00NoNoCurrent
65862-286-536586202865312000 TABLET in 1 BAG (65862-286-53)12000 tablet10-NOV-09Current