Enalapril Maleate

Product NDC
60429-183
Requested package NDC
60429-183-10
11-digit product format
604290183
Labeler code
60429
Product ID
60429-183_2b9f8c8d-e16a-2bb6-e063-6294a90a164e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA075657
Marketing category
ANDA
Marketing start
2001-01-23
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 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
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 · 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 UTC2026-02A075657-001ENALAPRIL 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…
2024-10-29 15:01 UTC2024-10A075657-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2001-01-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A075657-002ENALAPRIL MALEATE5MGTABLET / ORALAB2001-01-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A075657-003ENALAPRIL MALEATE10MGTABLET / ORALAB2001-01-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A075657-004ENALAPRIL MALEATE20MGTABLET / ORALAB2001-01-23d06236e962d9…

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 UTC2026-02A075657-001AB1011fe1cb6892…
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…
2024-10-29 15:01 UTC2024-10A075657-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075657-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075657-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075657-004AB1d06236e962d9…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 MALEATEBryant Ranch Prepackfb3c7066-76cb-4e8e-b98b-bcb41a3631df2025-10-16Boxed 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
ndc (package): 60429-183-10
ndc (product): 60429-183
ndc11 (package): 60429018310
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackbdb34c96-1532-4ce5-93a7-3cc90904c9102024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075657
application number: ANDA075657
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

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
0a12343f-5733-40cc-93b4-a02f5147fb91Available 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
60429-183-10Enalapril Maleate1000 in 1 BOTTLETABLET100011
60429-183-30Enalapril Maleate30 in 1 BOTTLETABLET3011
60429-183-90Enalapril Maleate90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-183-10EA - Each60429-18398ef593d-360c-41c6-b7f0-9fb54868a59a12014-05-02
60429-183-30EA - Each60429-183a622fc88-359f-46a0-a7fa-509b0749410e12014-05-02
60429-183-90EA - Each60429-18383be17b7-9111-41dd-b185-b6384288832212014-05-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-183ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]11Current NDC, Legacy NDC, 3 package rows20250126_0a12343f-5733-40cc-93b4-a02f5147fb91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSN0a12343f-5733-40cc-93b4-a02f5147fb9111
858804enalapril maleate 2.5 MG Oral TabletPSN0a12343f-5733-40cc-93b4-a02f5147fb9111
858810enalapril maleate 20 MG Oral TabletPSN0a12343f-5733-40cc-93b4-a02f5147fb9111
858813enalapril maleate 5 MG Oral TabletPSN0a12343f-5733-40cc-93b4-a02f5147fb9111
858817enalapril maleate 10 MG Oral TabletSCD0a12343f-5733-40cc-93b4-a02f5147fb9111
858804enalapril maleate 2.5 MG Oral TabletSCD0a12343f-5733-40cc-93b4-a02f5147fb9111
858810enalapril maleate 20 MG Oral TabletSCD0a12343f-5733-40cc-93b4-a02f5147fb9111
858813enalapril maleate 5 MG Oral TabletSCD0a12343f-5733-40cc-93b4-a02f5147fb9111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-183-10604290183101000 TABLET in 1 BOTTLE (60429-183-10) 1000 tablet2013-11-040000-00-00NoNoCurrent