ENALAPRIL MALEATE

Product NDC
21695-489
11-digit product format
216950489
Labeler code
21695
Product ID
21695-489_53ac99fe-8ff3-4a6f-b90e-d602e1019acb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRIL MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA075483
Marketing category
ANDA
Marketing start
2009-12-11
Marketing end
0000-00-00
Substance
ENALAPRIL MALEATE
Active strength
20 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
excluded productproduct21695-489IInactivated by FDA2026-09-14
excluded packagepackage21695-48921695-489-90IInactivated by FDA2026-09-14

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 · 44 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 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-489-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-489-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-489-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-489-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-489-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-489-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-489-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-489-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-489-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-489-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-489-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-489-90557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-489-908af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-489-90834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-489-901332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-489-90fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-489-9086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-489-90bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-489-908dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-489-90e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-489-909bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-489-90110d247fa046…a55b01930146…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075483-001ENALAPRIL MALEATEENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22
A075483-002ENALAPRIL MALEATEENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22
A075483-003ENALAPRIL MALEATEENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22
A075483-004ENALAPRIL MALEATEENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A075483-001AB
A075483-002AB
A075483-003AB
A075483-004AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-2284e616aacf4f…
2026-09-14 22:38:342026-08A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-2284e616aacf4f…
2026-09-14 22:38:342026-08A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-2284e616aacf4f…
2026-09-14 22:38:342026-08A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-2284e616aacf4f…
2026-08-18 06:07:402026-07A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-225bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075483-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A075483-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A075483-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A075483-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A075483-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075483-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075483-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ffbd585-373a-fcf5-c6c8-1f04bf28013eProduct name320250331
2c0b09af-323c-477d-9a19-d8165aefa3b0Product name420250107
628e4aea-ca7c-e8c4-6fcc-d791c4deb0aeProduct name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-489-902019-09-24C16284748780-1934fe258-4d16-48b1-e053-8cdaa90a720aEnalapril Maleate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-489-90ENALAPRIL MALEATE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-489-90EA - Each21695-4897790aec0-7c87-400f-931d-1a493641155312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENALAPRIL MALEATEACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
ENALAPRILACTIVE MOIETY69PN84IO1AENALAPRIL MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APENALAPRIL MALEATE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-489ENALAPRIL MALEATE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101126_53ac99fe-8ff3-4a6f-b90e-d602e1019acb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSN53ac99fe-8ff3-4a6f-b90e-d602e1019acb1
858810enalapril maleate 20 MG Oral TabletPSN53ac99fe-8ff3-4a6f-b90e-d602e1019acb1
858813enalapril maleate 5 MG Oral TabletPSN53ac99fe-8ff3-4a6f-b90e-d602e1019acb1
858817enalapril maleate 10 MG Oral TabletSCD53ac99fe-8ff3-4a6f-b90e-d602e1019acb1
858810enalapril maleate 20 MG Oral TabletSCD53ac99fe-8ff3-4a6f-b90e-d602e1019acb1
858813enalapril maleate 5 MG Oral TabletSCD53ac99fe-8ff3-4a6f-b90e-d602e1019acb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-489-902169504899090 in 1 BOTTLEHistorical