Enalapril Maleate

Product NDC
71205-075
11-digit product format
712050075
Labeler code
71205
Product ID
71205-075_bdfcb7c8-7269-46a6-aff8-d73b093ee88a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA018998
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1985-12-24
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
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Enalapril Maleate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENALAPRIL MALEATE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9O25354EPJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
858817Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cc921315-8da1-487c-ba19-433470f5c8d8Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-075-30Enalapril Maleate30 in 1 BOTTLETABLET303
71205-075-60Enalapril Maleate60 in 1 BOTTLETABLET603
71205-075-90Enalapril Maleate90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-075-90EA - Each71205-07572bef0e2-c4f2-4104-a5f7-9cd0effcf61d12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-075ENALAPRIL MALEATE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191030_cc921315-8da1-487c-ba19-433470f5c8d8.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
ndc (product): 71205-075

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSNcc921315-8da1-487c-ba19-433470f5c8d83
858817enalapril maleate 10 MG Oral TabletSCDcc921315-8da1-487c-ba19-433470f5c8d83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-075-307120500753030 TABLET in 1 BOTTLE (71205-075-30) 30 tablet2018-07-020000-00-00NoNoCurrent
71205-075-607120500756060 TABLET in 1 BOTTLE (71205-075-60) 60 tablet2018-07-020000-00-00NoNoCurrent
71205-075-907120500759090 TABLET in 1 BOTTLE (71205-075-90) 90 tablet2018-07-020000-00-00NoNoCurrent