ENALAPRIL MALEATE

Product NDC
55648-926
11-digit product format
556480926
Labeler code
55648
Product ID
55648-926_c6ea4a09-66d5-4f33-9f17-9c63cb59e4b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRIL MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
Wockhardt Limited
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
No
Listing certified through
2019-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55648-926IInactivated by FDA2026-08-17
excluded packagepackage55648-92655648-926-01IInactivated by FDA2026-08-17
excluded packagepackage55648-92655648-926-02IInactivated by FDA2026-08-17
excluded packagepackage55648-92655648-926-03IInactivated by FDA2026-08-17
excluded packagepackage55648-92655648-926-07IInactivated by FDA2026-08-17
excluded packagepackage55648-92655648-926-09IInactivated by FDA2026-08-17
excluded packagepackage55648-92655648-926-10IInactivated 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 3 · 147 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 packagepackage55648-926-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-926-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-926-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-926-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-926-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-926-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-926-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-926-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-926-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-926-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-926-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-926-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-926-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-926-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-926-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-926-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-926-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-926-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-926-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-926-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-926-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-926-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-926-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-926-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-926-09cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-926-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-926-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-926-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-926-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-926-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-926-09cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-926-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-926-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-926-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-926-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-926-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-926-09302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-926-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-926-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-926-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-926-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-926-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-926-09ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-926-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-926-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-926-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-926-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-926-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-926-090efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-926-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-926-070efc9e666f02…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
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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075483-001ENALAPRIL 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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22d8e5a09893c0…

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 06:07:402026-07A075483-001AB1caaa826d4ba7…
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-004AB1d8e5a09893c0…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-926-01ENALAPRIL MALEATE90 in 1 BOTTLETABLET903
55648-926-02ENALAPRIL MALEATE100 in 1 BOTTLETABLET1003
55648-926-03ENALAPRIL MALEATE1000 in 1 BOTTLETABLET10003
55648-926-07ENALAPRIL MALEATE10 in 1 CARTONTABLET103
55648-926-07ENALAPRIL MALEATE10 in 1 BLISTER PACKTABLET103
55648-926-09ENALAPRIL MALEATE40000 in 1 DRUMTABLET400003
55648-926-10ENALAPRIL MALEATE8000 in 1 DRUMTABLET80003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENALAPRIL MALEATEACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]3
ENALAPRILAT ANHYDROUSACTIVE MOIETYQ508Q118JMENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]3
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]3
TALCINACTIVE INGREDIENT7SEV7J4R1UENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-926ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]3Legacy NDC, 7 package rows20151124_f1ec6ac1-6b94-40bb-a329-9056f201090c.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
ENALAPRIL MALEATEENALAPRIL MALEATEAmici Pharma, Inca88902bd-742f-4ea6-b625-cc9df1709efc2025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075483
application number: ANDA075483

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSNf1ec6ac1-6b94-40bb-a329-9056f201090c3
858804enalapril maleate 2.5 MG Oral TabletPSNf1ec6ac1-6b94-40bb-a329-9056f201090c3
858810enalapril maleate 20 MG Oral TabletPSNf1ec6ac1-6b94-40bb-a329-9056f201090c3
858813enalapril maleate 5 MG Oral TabletPSNf1ec6ac1-6b94-40bb-a329-9056f201090c3
858817enalapril maleate 10 MG Oral TabletSCDf1ec6ac1-6b94-40bb-a329-9056f201090c3
858804enalapril maleate 2.5 MG Oral TabletSCDf1ec6ac1-6b94-40bb-a329-9056f201090c3
858810enalapril maleate 20 MG Oral TabletSCDf1ec6ac1-6b94-40bb-a329-9056f201090c3
858813enalapril maleate 5 MG Oral TabletSCDf1ec6ac1-6b94-40bb-a329-9056f201090c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-926-015564809260190 in 1 BOTTLEHistorical
55648-926-0255648092602100 in 1 BOTTLEHistorical
55648-926-03556480926031000 in 1 BOTTLEHistorical
55648-926-075564809260710 in 1 CARTONHistorical
55648-926-095564809260940000 in 1 DRUMHistorical
55648-926-10556480926108000 in 1 DRUMHistorical