Enalapril maleate

Product NDC
23155-704
11-digit product format
231550704
Labeler code
23155
Product ID
23155-704_f59f9ce5-246c-47c9-a171-aee4cc1c09a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril maleate
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA075479
Marketing category
ANDA
Marketing start
2020-04-28
Substance
ENALAPRIL MALEATE
Active strength
2.5 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
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
A075479-001ENALAPRIL MALEATEENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22
A075479-002ENALAPRIL MALEATEENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22
A075479-003ENALAPRIL MALEATEENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22
A075479-004ENALAPRIL 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
A075479-001AB
A075479-002AB
A075479-003AB
A075479-004AB

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 06:07:402026-07A075479-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A075479-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A075479-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A075479-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075479-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075479-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075479-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075479-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075479-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075479-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075479-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075479-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075479-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075479-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075479-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075479-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075479-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075479-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075479-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075479-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075479-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075479-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075479-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075479-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075479-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075479-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075479-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075479-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075479-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075479-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075479-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075479-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075479-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075479-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075479-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075479-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075479-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075479-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075479-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075479-004ENALAPRIL 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 06:07:402026-07A075479-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075479-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075479-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075479-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075479-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075479-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075479-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075479-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075479-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075479-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075479-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075479-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075479-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075479-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075479-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075479-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075479-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075479-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075479-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075479-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075479-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075479-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075479-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075479-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075479-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075479-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075479-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075479-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075479-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075479-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075479-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075479-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075479-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075479-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075479-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075479-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075479-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075479-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075479-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075479-004AB1d8e5a09893c0…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENALAPRIL MALEATE2.5 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
5c49fb37-1f09-4965-b213-5580d3a30a11Available 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
23155-704-01Enalapril maleate100 in 1 BOTTLETABLET1007
23155-704-10Enalapril maleate1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-704-01EA - Each23155-7041feeec95-e944-4a68-bcfc-673c7539a94a12020-08-06
23155-704-10EA - Each23155-704fea846de-237c-49bc-840e-e79d5422e2ac12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-704ENALAPRIL MALEATE TABLET ENALAPRIL MALEATE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20240301_5c49fb37-1f09-4965-b213-5580d3a30a11.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Enalapril maleateENALAPRIL MALEATEA-S Medication Solutions9f913e79-fe6d-4ff2-9f8e-eef9df689fa82026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075479
application number: ANDA075479
Enalapril maleateENALAPRIL MALEATELegacy Pharmaceutical Packaging, LLCed7536f1-9a7d-4519-e053-2a95a90a4a652026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075479
application number: ANDA075479
Enalapril maleateENALAPRIL MALEATEMajor Pharmaceuticals8fe8dc52-dee6-4d33-b798-e90128011f462026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075479
application number: ANDA075479
Enalapril maleateENALAPRIL MALEATENorthwind Health Company, LLCf29ef93b-7380-2196-e053-2995a90a2ce32026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075479
application number: ANDA075479
Enalapril maleateENALAPRIL MALEATENorthwind Health Company, LLCf2a0bd73-0389-3f88-e053-2995a90a72e82026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075479
application number: ANDA075479
Enalapril maleateENALAPRIL MALEATENorthwind Health Company, LLCf2b3776b-02a1-311b-e053-2a95a90a2f9b2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075479
application number: ANDA075479
Enalapril maleateENALAPRIL MALEATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.5c49fb37-1f09-4965-b213-5580d3a30a112025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075479
application number: ANDA075479
ndc (product): 23155-704
Enalapril maleateENALAPRIL MALEATEREMEDYREPACK INC.7077d32e-4b06-4d48-ba0c-6db2f8ebe08c2025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075479
application number: ANDA075479
Enalapril maleateENALAPRIL MALEATEChartwell RX, LLCb1df1832-dce4-443f-87fc-e4177d0690352024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075479
application number: ANDA075479
Enalapril maleateENALAPRIL MALEATEA-S Medication Solutionsccdd0f67-e9d5-41e3-93d5-94b9792a6f8f2023-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075479
application number: ANDA075479

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSN5c49fb37-1f09-4965-b213-5580d3a30a117
858804enalapril maleate 2.5 MG Oral TabletPSN5c49fb37-1f09-4965-b213-5580d3a30a117
858810enalapril maleate 20 MG Oral TabletPSN5c49fb37-1f09-4965-b213-5580d3a30a117
858813enalapril maleate 5 MG Oral TabletPSN5c49fb37-1f09-4965-b213-5580d3a30a117
858817enalapril maleate 10 MG Oral TabletSCD5c49fb37-1f09-4965-b213-5580d3a30a117
858804enalapril maleate 2.5 MG Oral TabletSCD5c49fb37-1f09-4965-b213-5580d3a30a117
858810enalapril maleate 20 MG Oral TabletSCD5c49fb37-1f09-4965-b213-5580d3a30a117
858813enalapril maleate 5 MG Oral TabletSCD5c49fb37-1f09-4965-b213-5580d3a30a117
858817enalapril maleate 10 MG Oral TabletPSN8fe8dc52-dee6-4d33-b798-e90128011f463
858804enalapril maleate 2.5 MG Oral TabletPSN8fe8dc52-dee6-4d33-b798-e90128011f463
858810enalapril maleate 20 MG Oral TabletPSN8fe8dc52-dee6-4d33-b798-e90128011f463
858813enalapril maleate 5 MG Oral TabletPSN8fe8dc52-dee6-4d33-b798-e90128011f463
858817enalapril maleate 10 MG Oral TabletSCD8fe8dc52-dee6-4d33-b798-e90128011f463
858804enalapril maleate 2.5 MG Oral TabletSCD8fe8dc52-dee6-4d33-b798-e90128011f463
858810enalapril maleate 20 MG Oral TabletSCD8fe8dc52-dee6-4d33-b798-e90128011f463
858813enalapril maleate 5 MG Oral TabletSCD8fe8dc52-dee6-4d33-b798-e90128011f463

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-704-0123155070401100 TABLET in 1 BOTTLE (23155-704-01) 100 tablet2020-04-280000-00-00NoNoCurrent
23155-704-10231550704101000 TABLET in 1 BOTTLE (23155-704-10) 1000 tablet2020-04-280000-00-00NoNoCurrent