ENALAPRIL MALEATE

Product NDC
72189-151
11-digit product format
721890151
Labeler code
72189
Product ID
72189-151_b3ee3b05-8741-cd17-e053-2a95a90a6e28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRIL MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
direct rx
Application
ANDA075657
Marketing category
ANDA
Marketing start
2020-11-12
Marketing end
0000-00-00
Substance
ENALAPRIL MALEATE
Active strength
10 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct72189-151IInactivated by FDA2026-08-17
excluded packagepackage72189-15172189-151-90IInactivated by FDA2026-08-17

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72189-151-90IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72189-151-90IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage72189-151-90IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage72189-151-90IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage72189-151-90IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage72189-151-90IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72189-151-90UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-151-90UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-151-90UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075657-001ENALAPRIL MALEATEENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-23
A075657-002ENALAPRIL MALEATEENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-23
A075657-003ENALAPRIL MALEATEENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-23
A075657-004ENALAPRIL MALEATEENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075657-001AB
A075657-002AB
A075657-003AB
A075657-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-23caaa826d4ba7…
2026-08-18 06:07:402026-07A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-23caaa826d4ba7…
2026-08-18 06:07:402026-07A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-23caaa826d4ba7…
2026-08-18 06:07:402026-07A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-23d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075657-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075657-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075657-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075657-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075657-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075657-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075657-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075657-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075657-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075657-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075657-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075657-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075657-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075657-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075657-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075657-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075657-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075657-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075657-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075657-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075657-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075657-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075657-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075657-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075657-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075657-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075657-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075657-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075657-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075657-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075657-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075657-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075657-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075657-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075657-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075657-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075657-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075657-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075657-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075657-004AB1d8e5a09893c0…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ffbd585-373a-fcf5-c6c8-1f04bf28013eProduct name320250331
2c0b09af-323c-477d-9a19-d8165aefa3b0Product name420250107
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
628e4aea-ca7c-e8c4-6fcc-d791c4deb0aeProduct name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-151-902025-01-30C16284748780-12cef2736-6b0e-d83d-e063-dadaa90ab31fENALAPRIL MALEATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-151-90ENALAPRIL MALEATE90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-151ENALAPRIL MALEATE TABLET [DIRECT RX]1Legacy NDC, 1 package rows20201113_b3ee3b05-8740-cd17-e053-2a95a90a6e28.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackfb3c7066-76cb-4e8e-b98b-bcb41a3631df2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATESun Pharmaceutical Industries, Inc.f103b9f9-e081-419d-a2d8-b86acda834dd2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepack7fdc2d8a-9b5d-43c4-b32f-6f2505aee33c2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEA-S Medication Solutionsbc875f91-d781-43a9-8f7e-e2cfc019ad3f2026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATENorthwind Health Company, LLCab2ffb6e-4628-e44c-e053-2a95a90a23362026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.3fbc6cce-7ad5-49d5-9705-5f66ef92d5442025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEGolden State Medical Supply, Inc.0a12343f-5733-40cc-93b4-a02f5147fb912025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackbdb34c96-1532-4ce5-93a7-3cc90904c9102024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepack2061543d-67e7-46b6-aa56-cafa11ae4b932024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEA-S Medication Solutions0ad4bfb4-62db-4759-af60-88eb031d125a2023-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEGolden State Medical Supply, Inc.074fe718-88d8-365c-e063-6394a90a299d2023-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEA-S Medication Solutionsf3754f29-9b75-4e2c-9c28-b3479f5bf9062023-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackb4b7b936-4a62-4991-8d3c-03bb37f044c12023-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEProficient Rx LPca1d0143-bbd3-4041-9981-eadbb8893a2b2020-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSNb3ee3b05-8740-cd17-e053-2a95a90a6e281
858817enalapril maleate 10 MG Oral TabletSCDb3ee3b05-8740-cd17-e053-2a95a90a6e281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-151-907218901519090 TABLET in 1 BOTTLE (72189-151-90) 90 tablet2020-11-120000-00-00NoNoCurrent