Enalapril Maleate

Product NDC
71335-1910
11-digit product format
713351910
Labeler code
71335
Product ID
71335-1910_5aa8f072-39b8-4c7d-b80f-5b1d938ecada
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075657
Marketing category
ANDA
Marketing start
2001-01-23
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
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
A075657-001ENALAPRIL MALEATEENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-23
A075657-002ENALAPRIL MALEATEENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-23
A075657-003ENALAPRIL MALEATEENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-23
A075657-004ENALAPRIL MALEATEENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075657-001AB
A075657-002AB
A075657-003AB
A075657-004AB

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 06:07:402026-07A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-23caaa826d4ba7…
2026-08-18 06:07:402026-07A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-23caaa826d4ba7…
2026-08-18 06:07:402026-07A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-23caaa826d4ba7…
2026-08-18 06:07:402026-07A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-23d8e5a09893c0…

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 06:07:402026-07A075657-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075657-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075657-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075657-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075657-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075657-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075657-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075657-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075657-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075657-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075657-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075657-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075657-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075657-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075657-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075657-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075657-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075657-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075657-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075657-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075657-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075657-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075657-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075657-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075657-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075657-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075657-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075657-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075657-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075657-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075657-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075657-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075657-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075657-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075657-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075657-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075657-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075657-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075657-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075657-004AB1d8e5a09893c0…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENALAPRIL MALEATE5 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
858813Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bdb34c96-1532-4ce5-93a7-3cc90904c910Available 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
71335-1910-1Enalapril Maleate150 in 1 BOTTLETABLET150102
71335-1910-2Enalapril Maleate100 in 1 BOTTLETABLET100102
71335-1910-3Enalapril Maleate30 in 1 BOTTLETABLET30102
71335-1910-4Enalapril Maleate60 in 1 BOTTLETABLET60102
71335-1910-5Enalapril Maleate90 in 1 BOTTLETABLET90102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1910ENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20240415_bdb34c96-1532-4ce5-93a7-3cc90904c910.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackfb3c7066-76cb-4e8e-b98b-bcb41a3631df2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATESun Pharmaceutical Industries, Inc.f103b9f9-e081-419d-a2d8-b86acda834dd2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepack7fdc2d8a-9b5d-43c4-b32f-6f2505aee33c2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEA-S Medication Solutionsbc875f91-d781-43a9-8f7e-e2cfc019ad3f2026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATENorthwind Health Company, LLCab2ffb6e-4628-e44c-e053-2a95a90a23362026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.3fbc6cce-7ad5-49d5-9705-5f66ef92d5442025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEGolden State Medical Supply, Inc.0a12343f-5733-40cc-93b4-a02f5147fb912025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackbdb34c96-1532-4ce5-93a7-3cc90904c9102024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
ndc (product): 71335-1910
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepack2061543d-67e7-46b6-aa56-cafa11ae4b932024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEA-S Medication Solutions0ad4bfb4-62db-4759-af60-88eb031d125a2023-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEGolden State Medical Supply, Inc.074fe718-88d8-365c-e063-6394a90a299d2023-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEA-S Medication Solutionsf3754f29-9b75-4e2c-9c28-b3479f5bf9062023-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackb4b7b936-4a62-4991-8d3c-03bb37f044c12023-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
Enalapril MaleateENALAPRIL MALEATEProficient Rx LPca1d0143-bbd3-4041-9981-eadbb8893a2b2020-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858813enalapril maleate 5 MG Oral TabletPSNbdb34c96-1532-4ce5-93a7-3cc90904c910102
858813enalapril maleate 5 MG Oral TabletSCDbdb34c96-1532-4ce5-93a7-3cc90904c910102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1910-171335191001150 TABLET in 1 BOTTLE (71335-1910-1) 150 tablet2024-04-050000-00-00NoNoCurrent
71335-1910-271335191002100 TABLET in 1 BOTTLE (71335-1910-2) 100 tablet2023-10-270000-00-00NoNoCurrent
71335-1910-37133519100330 TABLET in 1 BOTTLE (71335-1910-3) 30 tablet2021-09-170000-00-00NoNoCurrent
71335-1910-47133519100460 TABLET in 1 BOTTLE (71335-1910-4) 60 tablet2024-04-050000-00-00NoNoCurrent
71335-1910-57133519100590 TABLET in 1 BOTTLE (71335-1910-5) 90 tablet2021-08-110000-00-00NoNoCurrent