Enalapril Maleate

Product NDC
50090-5292
11-digit product format
500905292
Labeler code
50090
Product ID
50090-5292_58332e34-a6a4-41af-a8af-df50d5296ed0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA018998
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1985-12-24
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
2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-5292IInactivated by FDA2026-08-17
excluded packagepackage50090-529250090-5292-0IInactivated by FDA2026-08-17
excluded packagepackage50090-529250090-5292-1IInactivated 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 · 45 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 packagepackage50090-5292-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-5292-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-5292-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-5292-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-5292-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-5292-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-5292-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-5292-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-5292-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-5292-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-5292-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-5292-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-5292-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-5292-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-5292-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-5292-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-5292-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-5292-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-5292-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-5292-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-5292-0367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-5292-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-5292-0557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-5292-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-5292-08af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-5292-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-5292-0834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-5292-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-5292-01332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-5292-11332a3947898…d4bfe170f9cd…

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
N018998-001VASOTECENALAPRIL MALEATE5MGTABLET / ORALABRLD1985-12-24
N018998-002VASOTECENALAPRIL MALEATE10MGTABLET / ORALABRLD1985-12-24
N018998-003VASOTECENALAPRIL MALEATE20MGTABLET / ORALABRLD, RS1985-12-24
N018998-005VASOTECENALAPRIL MALEATE2.5MGTABLET / ORALABRLD1988-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018998-001AB
N018998-002AB
N018998-003AB
N018998-005AB

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 06:07:402026-07N018998-001VASOTEC5MGTABLET / ORALABRLD1985-12-24caaa826d4ba7…
2026-08-18 06:07:402026-07N018998-002VASOTEC10MGTABLET / ORALABRLD1985-12-24caaa826d4ba7…
2026-08-18 06:07:402026-07N018998-003VASOTEC20MGTABLET / ORALABRLD, RS1985-12-24caaa826d4ba7…
2026-08-18 06:07:402026-07N018998-005VASOTEC2.5MGTABLET / ORALABRLD1988-07-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018998-001VASOTEC5MGTABLET / ORALABRLD1985-12-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018998-002VASOTEC10MGTABLET / ORALABRLD1985-12-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018998-003VASOTEC20MGTABLET / ORALABRLD, RS1985-12-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018998-005VASOTEC2.5MGTABLET / ORALABRLD1988-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018998-001VASOTEC5MGTABLET / ORALABRLD1985-12-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018998-002VASOTEC10MGTABLET / ORALABRLD1985-12-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018998-003VASOTEC20MGTABLET / ORALABRLD, RS1985-12-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018998-005VASOTEC2.5MGTABLET / ORALABRLD1988-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N018998-001VASOTEC5MGTABLET / ORALABRLD1985-12-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018998-002VASOTEC10MGTABLET / ORALABRLD1985-12-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018998-003VASOTEC20MGTABLET / ORALABRLD, RS1985-12-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018998-005VASOTEC2.5MGTABLET / ORALABRLD1988-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018998-001VASOTEC5MGTABLET / ORALABRLD1985-12-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018998-002VASOTEC10MGTABLET / ORALABRLD1985-12-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018998-003VASOTEC20MGTABLET / ORALABRLD, RS1985-12-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018998-005VASOTEC2.5MGTABLET / ORALABRLD1988-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018998-001VASOTEC5MGTABLET / ORALABRLD1985-12-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018998-002VASOTEC10MGTABLET / ORALABRLD1985-12-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018998-003VASOTEC20MGTABLET / ORALABRLD, RS1985-12-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018998-005VASOTEC2.5MGTABLET / ORALABRLD1988-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018998-001VASOTEC5MGTABLET / ORALABRLD1985-12-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018998-002VASOTEC10MGTABLET / ORALABRLD1985-12-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018998-003VASOTEC20MGTABLET / ORALABRLD, RS1985-12-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018998-005VASOTEC2.5MGTABLET / ORALABRLD1988-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018998-001VASOTEC5MGTABLET / ORALABRLD1985-12-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018998-002VASOTEC10MGTABLET / ORALABRLD1985-12-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018998-003VASOTEC20MGTABLET / ORALABRLD, RS1985-12-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018998-005VASOTEC2.5MGTABLET / ORALABRLD1988-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018998-001VASOTEC5MGTABLET / ORALABRLD1985-12-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018998-002VASOTEC10MGTABLET / ORALABRLD1985-12-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018998-003VASOTEC20MGTABLET / ORALABRLD, RS1985-12-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018998-005VASOTEC2.5MGTABLET / ORALABRLD1988-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018998-001VASOTEC5MGTABLET / ORALABRLD1985-12-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018998-002VASOTEC10MGTABLET / ORALABRLD1985-12-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018998-003VASOTEC20MGTABLET / ORALABRLD, RS1985-12-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018998-005VASOTEC2.5MGTABLET / ORALABRLD1988-07-26d8e5a09893c0…

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 06:07:402026-07N018998-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N018998-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N018998-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N018998-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018998-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018998-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018998-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018998-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018998-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018998-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018998-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018998-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018998-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018998-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018998-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018998-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018998-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018998-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018998-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018998-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018998-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018998-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018998-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018998-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018998-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018998-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018998-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018998-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018998-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018998-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018998-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018998-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018998-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018998-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018998-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018998-005AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018998-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018998-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018998-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018998-005AB1d8e5a09893c0…

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
50090-5292-02023-01-30C16284748780-1f386c649-d2a2-0266-e053-dadaa90a7c1aEnalapril Maleate Tablets
50090-5292-12023-01-30C16284748780-1f386c649-d2a2-0266-e053-dadaa90a7c1aEnalapril Maleate Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5292-0Enalapril Maleate30 in 1 BOTTLETABLET305
50090-5292-1Enalapril Maleate100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5292-1EA - Each50090-52926c73146b-83d3-41cc-b900-04c325a016b312022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5292ENALAPRIL MALEATE TABLET [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20210416_cc771cfb-122e-4784-b293-b8a2f824eacf.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VasotecENALAPRIL MALEATEBausch Health US LLC39631f1f-5d19-43c1-b504-bf56d991ed972026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018998
application number: NDA018998
Enalapril MaleateENALAPRIL MALEATEOCEANSIDE PHARMACEUTICALSebd2a62d-a704-4f8a-a104-749a5296502f2020-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018998
application number: NDA018998
Enalapril MaleateENALAPRIL MALEATEProficient Rx LPcc921315-8da1-487c-ba19-433470f5c8d82019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018998
application number: NDA018998

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858813enalapril maleate 5 MG Oral TabletPSNcc771cfb-122e-4784-b293-b8a2f824eacf5
858813enalapril maleate 5 MG Oral TabletSCDcc771cfb-122e-4784-b293-b8a2f824eacf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5292-05009052920030 TABLET in 1 BOTTLE (50090-5292-0) 30 tablet2020-10-230000-00-00NoNoCurrent
50090-5292-150090529201100 TABLET in 1 BOTTLE (50090-5292-1) 100 tablet2020-10-230000-00-00NoNoCurrent