Vasotec

Product NDC
0187-0143
11-digit product format
001870143
Labeler code
0187
Product ID
0187-0143_1be6ec2b-1c20-4ff4-a8ff-cd23e3de9fa4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Bausch Health US LLC
Application
NDA018998
Marketing category
NDA
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
2027-12-31
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
Vasotec
Listing expiration
2027-12-31

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 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
858804Internal RxNorm lookup
858806Internal RxNorm lookup
858810Internal RxNorm lookup
858812Internal RxNorm lookup
858813Internal RxNorm lookup
858815Internal RxNorm lookup
858817Internal RxNorm lookup
858819Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
39631f1f-5d19-43c1-b504-bf56d991ed97Available 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
0187-0143-10Vasotec1000 in 1 BOTTLETABLET100015
0187-0143-30Vasotec30 in 1 BOTTLETABLET3015
0187-0143-90Vasotec90 in 1 BOTTLETABLET9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-0143-10EA - Each0187-014331320af4-76d4-4557-b8fb-ec4d0819e94412013-03-03
0187-0143-30EA - Each0187-0143aefc26cd-c1ee-44ff-91e3-35b6ed1ffb9f12013-02-13
0187-0143-90EA - Each0187-01434abe8822-d3b4-4b6b-9ecc-cbb5bbeccc4812013-03-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-0143VASOTEC (ENALAPRIL MALEATE) TABLET [BAUSCH HEALTH US LLC]13Current NDC, Legacy NDC, 3 package rows20210303_39631f1f-5d19-43c1-b504-bf56d991ed97.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
ndc (product): 0187-0143
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
858817enalapril maleate 10 MG Oral TabletPSN39631f1f-5d19-43c1-b504-bf56d991ed9715
858804enalapril maleate 2.5 MG Oral TabletPSN39631f1f-5d19-43c1-b504-bf56d991ed9715
858810enalapril maleate 20 MG Oral TabletPSN39631f1f-5d19-43c1-b504-bf56d991ed9715
858813enalapril maleate 5 MG Oral TabletPSN39631f1f-5d19-43c1-b504-bf56d991ed9715
858819Vasotec 10 MG Oral TabletPSN39631f1f-5d19-43c1-b504-bf56d991ed9715
858806Vasotec 2.5 MG Oral TabletPSN39631f1f-5d19-43c1-b504-bf56d991ed9715
858812Vasotec 20 MG Oral TabletPSN39631f1f-5d19-43c1-b504-bf56d991ed9715
858815Vasotec 5 MG Oral TabletPSN39631f1f-5d19-43c1-b504-bf56d991ed9715
858819enalapril maleate 10 MG Oral Tablet [Vasotec]SBD39631f1f-5d19-43c1-b504-bf56d991ed9715
858806enalapril maleate 2.5 MG Oral Tablet [Vasotec]SBD39631f1f-5d19-43c1-b504-bf56d991ed9715
858812enalapril maleate 20 MG Oral Tablet [Vasotec]SBD39631f1f-5d19-43c1-b504-bf56d991ed9715
858815enalapril maleate 5 MG Oral Tablet [Vasotec]SBD39631f1f-5d19-43c1-b504-bf56d991ed9715
858817enalapril maleate 10 MG Oral TabletSCD39631f1f-5d19-43c1-b504-bf56d991ed9715
858804enalapril maleate 2.5 MG Oral TabletSCD39631f1f-5d19-43c1-b504-bf56d991ed9715
858810enalapril maleate 20 MG Oral TabletSCD39631f1f-5d19-43c1-b504-bf56d991ed9715
858813enalapril maleate 5 MG Oral TabletSCD39631f1f-5d19-43c1-b504-bf56d991ed9715
858819Vasotec 10 MG Oral TabletSY39631f1f-5d19-43c1-b504-bf56d991ed9715
858806Vasotec 2.5 MG Oral TabletSY39631f1f-5d19-43c1-b504-bf56d991ed9715
858812Vasotec 20 MG Oral TabletSY39631f1f-5d19-43c1-b504-bf56d991ed9715
858815Vasotec 5 MG Oral TabletSY39631f1f-5d19-43c1-b504-bf56d991ed9715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-0143-10001870143101000 TABLET in 1 BOTTLE (0187-0143-10) 1000 tablet1985-12-240000-00-00NoNoCurrent
0187-0143-300018701433030 TABLET in 1 BOTTLE (0187-0143-30) 30 tablet1985-12-240000-00-00NoNoCurrent
0187-0143-900018701439090 TABLET in 1 BOTTLE (0187-0143-90) 90 tablet1985-12-240000-00-00NoNoCurrent