Enalapril Maleate

Product NDC
70518-1374
11-digit product format
705181374
Labeler code
70518
Product ID
70518-1374_92a311ff-2eb3-5b3e-e053-2995a90a8577
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075657
Marketing category
ANDA
Marketing start
2018-08-15
Marketing end
0000-00-00
Substance
ENALAPRIL MALEATE
Active strength
5 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
2020-12-31
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 productproduct70518-1374DDiscontinued by firm2026-08-17
excluded packagepackage70518-137470518-1374-0DDiscontinued by firm2026-08-17

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 · 24 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 packagepackage70518-1374-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-1374-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-1374-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-1374-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-1374-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-1374-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-1374-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-1374-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-1374-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-1374-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-1374-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-1374-0557ba5c1ecfa…9c80585c8c6e…

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…

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