Enalapril Maleate

Product NDC
0378-1052
11-digit product format
003781052
Labeler code
0378
Product ID
0378-1052_62025f28-0d2f-45c7-9e22-010086ff1bb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA075480
Marketing category
ANDA
Marketing start
2000-08-22
Marketing end
2019-04-30
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
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-1052DDiscontinued by firm2026-08-17
excluded packagepackage0378-10520378-1052-01DDiscontinued by firm2026-08-17
excluded packagepackage0378-10520378-1052-10DDiscontinued 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 · 36 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 packagepackage0378-1052-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0378-1052-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-1052-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-1052-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-1052-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-1052-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-1052-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-1052-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-1052-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-1052-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-1052-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-1052-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-1052-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-1052-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-1052-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-1052-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-1052-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-1052-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-1052-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-1052-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-1052-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-1052-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-1052-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-1052-01557ba5c1ecfa…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
A075480-001ENALAPRIL MALEATEENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-22
A075480-002ENALAPRIL MALEATEENALAPRIL MALEATE5MGTABLET / ORAL2000-08-22
A075480-003ENALAPRIL MALEATEENALAPRIL MALEATE10MGTABLET / ORAL2000-08-22
A075480-004ENALAPRIL MALEATEENALAPRIL MALEATE20MGTABLET / ORAL2000-08-22

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 06:07:402026-07A075480-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A075480-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A075480-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A075480-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075480-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075480-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075480-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075480-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075480-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075480-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075480-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075480-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075480-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075480-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075480-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075480-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075480-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075480-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075480-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075480-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075480-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075480-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075480-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075480-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075480-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075480-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075480-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075480-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075480-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075480-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075480-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075480-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075480-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075480-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075480-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075480-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075480-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075480-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075480-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075480-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-22d8e5a09893c0…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1052-01EA - Each0378-1052c6449b2b-a57e-4236-8b7d-8d8d288507a812012-07-24
0378-1052-10EA - Each0378-1052c1df8649-c4f4-443d-a4ad-7c3dd51dc17212012-07-24

DailyMed Socrata Ingredients#