Enalapril Maleate

Product NDC
68682-713
Requested package NDC
68682-713-01
11-digit product format
686820713
Labeler code
68682
Product ID
68682-713_6771388d-89b3-43ec-b69e-9cebeaa2a00a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
OCEANSIDE PHARMACEUTICALS
Application
NDA018998
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1985-12-24
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-10-29 15:01 UTC2024-10N018998-001VASOTEC5MGTABLET / ORALABRLD1985-12-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N018998-002VASOTEC10MGTABLET / ORALABRLD1985-12-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N018998-003VASOTEC20MGTABLET / ORALABRLD, RS1985-12-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N018998-005VASOTEC2.5MGTABLET / ORALABRLD1988-07-26d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-10-29 15:01 UTC2024-10N018998-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018998-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018998-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018998-005AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENALAPRIL MALEATE20 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
858804Internal RxNorm lookup
858810Internal RxNorm lookup
858813Internal RxNorm lookup
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
ebd2a62d-a704-4f8a-a104-749a5296502fAvailable 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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
628e4aea-ca7c-e8c4-6fcc-d791c4deb0aeProduct name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68682-713-01Enalapril Maleate100 in 1 BOTTLETABLET1007
68682-713-10Enalapril Maleate1000 in 1 BOTTLETABLET10007
68682-713-30Enalapril Maleate30 in 1 BOTTLETABLET307
68682-713-90Enalapril Maleate90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-713-01EA - Each68682-71367f6eebd-9b33-4f4a-81f2-b59fe953d31512015-09-10
68682-713-10EA - Each68682-71315bfceb1-9f65-411c-9ab1-45f63a04ba0512015-09-10
68682-713-30EA - Each68682-713ec8bb062-4675-434a-97af-17d259b42ce112015-09-10
68682-713-90EA - Each68682-713eea81527-8950-4822-9bd5-a207bd9c945412015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Enalapril MaleateACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2
Enalaprilat AnhydrousACTIVE MOIETYQ508Q118JMENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2
ferric oxide redINACTIVE INGREDIENT1K09F3G675ENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2
lactoseINACTIVE INGREDIENTJ2B2A4N98GENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2
magnesium stearateINACTIVE INGREDIENT70097M6I30ENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2
sodium stearateINACTIVE INGREDIENTQU7E2XA9TGENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2
starch, cornINACTIVE INGREDIENTO8232NY3SJENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-713ENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]7Current NDC, Legacy NDC, 4 package rows20210305_ebd2a62d-a704-4f8a-a104-749a5296502f.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
ndc (package): 68682-713-01
ndc (product): 68682-713
ndc11 (package): 68682071301
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
858810enalapril maleate 20 MG Oral TabletPSN4d67c5a4-efb8-4543-96f3-ea9ffc940c51100
858810enalapril maleate 20 MG Oral TabletSCD4d67c5a4-efb8-4543-96f3-ea9ffc940c51100
858817enalapril maleate 10 MG Oral TabletPSNebd2a62d-a704-4f8a-a104-749a5296502f7
858804enalapril maleate 2.5 MG Oral TabletPSNebd2a62d-a704-4f8a-a104-749a5296502f7
858810enalapril maleate 20 MG Oral TabletPSNebd2a62d-a704-4f8a-a104-749a5296502f7
858813enalapril maleate 5 MG Oral TabletPSNebd2a62d-a704-4f8a-a104-749a5296502f7
858817enalapril maleate 10 MG Oral TabletSCDebd2a62d-a704-4f8a-a104-749a5296502f7
858804enalapril maleate 2.5 MG Oral TabletSCDebd2a62d-a704-4f8a-a104-749a5296502f7
858810enalapril maleate 20 MG Oral TabletSCDebd2a62d-a704-4f8a-a104-749a5296502f7
858813enalapril maleate 5 MG Oral TabletSCDebd2a62d-a704-4f8a-a104-749a5296502f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68682-713-0168682071301100 TABLET in 1 BOTTLE (68682-713-01) 100 tablet1985-12-240000-00-00NoNoCurrent