ENALAPRIL MALEATE

Product NDC
63629-1525
Requested package NDC
63629-1525-4
11-digit product format
636291525
Labeler code
63629
Product ID
63629-1525_51c1fc28-555f-4747-839d-5d3844f114bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRIL MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075483
Marketing category
ANDA
Marketing start
2009-12-11
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-152563629-1525-4DDiscontinued by firm2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075483-001ENALAPRIL MALEATEENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22
A075483-002ENALAPRIL MALEATEENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22
A075483-003ENALAPRIL MALEATEENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22
A075483-004ENALAPRIL 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
A075483-001AB
A075483-002AB
A075483-003AB
A075483-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-2284e616aacf4f…
2026-09-14 22:38:342026-08A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-2284e616aacf4f…
2026-09-14 22:38:342026-08A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-2284e616aacf4f…
2026-09-14 22:38:342026-08A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-2284e616aacf4f…
2026-08-18 06:07:402026-07A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-225bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075483-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A075483-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A075483-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A075483-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A075483-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075483-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075483-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1525-1EA - Each63629-152535daa56f-6c8a-4c6b-8445-38b8fd4ab34a12014-08-01
63629-1525-2EA - Each63629-1525779cb2a8-7844-474e-b831-028a188627a212014-08-01
63629-1525-3EA - Each63629-15253b4ebc18-b75e-4d7b-84b0-9ac102c9691412014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENALAPRIL MALEATEACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK]1000
ENALAPRILAT ANHYDROUSACTIVE MOIETYQ508Q118JMENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK]1000
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK]1000
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1525ENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK]1006Legacy NDC20230602_3f9d11af-24e3-423c-9f82-e7aca1010ce9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1525-46362915250490 TABLET in 1 BOTTLE (63629-1525-4) 90 tablet2009-12-110000-00-00NoNoCurrent