ENALAPRIL MALEATE

Product NDC
63629-1522
11-digit product format
636291522
Labeler code
63629
Product ID
63629-1522_165703a0-16d0-b7ff-5b66-88f1f7fa0600
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
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
2023-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-1522DDiscontinued by firm2026-10-21
excluded packagepackage63629-152263629-1522-1DDiscontinued by firm2026-10-21
excluded packagepackage63629-152263629-1522-2DDiscontinued by firm2026-10-21
excluded packagepackage63629-152263629-1522-3DDiscontinued by firm2026-10-21
excluded packagepackage63629-152263629-1522-4DDiscontinued by firm2026-10-21
excluded packagepackage63629-152263629-1522-5DDiscontinued by firm2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage63629-1522-5
excluded packagepackage63629-1522-1
excluded packagepackage63629-1522-2
excluded packagepackage63629-1522-4
excluded packagepackage63629-1522-3

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22c2088c7a36db…
2026-10-15 13:18:302026-09A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22c2088c7a36db…
2026-10-15 13:18:302026-09A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22c2088c7a36db…
2026-10-15 13:18:302026-09A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22c2088c7a36db…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075483-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075483-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075483-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075483-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075483-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075483-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075483-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075483-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075483-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075483-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075483-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075483-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075483-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075483-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075483-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075483-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075483-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075483-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075483-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075483-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075483-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075483-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075483-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075483-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075483-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075483-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075483-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075483-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075483-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075483-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075483-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075483-004AB14b0b4de00fa7…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1522-1EA - Each63629-1522a3ab7872-3a85-44a1-a432-89fa799bfec612012-07-24
63629-1522-2EA - Each63629-152231840a76-85f1-4483-99ce-0f26dc60b02012012-07-24
63629-1522-3EA - Each63629-1522a2926e37-801e-4656-b6cd-920cfa44711512012-07-24
63629-1522-4EA - Each63629-1522b47b2d5a-322e-42f6-8260-da950b6fdfae12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENALAPRIL MALEATEACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK]2
ENALAPRILACTIVE MOIETY69PN84IO1AENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1522ENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [BRYANT RANCH PREPACK]14Legacy NDC20230602_165703a0-16d0-b7ff-5b66-88f1f7fa0600.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1522-163629152201150 TABLET in 1 BOTTLE (63629-1522-1) 150 tablet2022-02-080000-00-00NoNoCurrent
63629-1522-263629152202100 TABLET in 1 BOTTLE (63629-1522-2) 100 tablet2014-04-110000-00-00NoNoCurrent
63629-1522-36362915220330 TABLET in 1 BOTTLE (63629-1522-3) 30 tablet2022-02-080000-00-00NoNoCurrent
63629-1522-46362915220460 TABLET in 1 BOTTLE (63629-1522-4) 60 tablet2022-02-080000-00-00NoNoCurrent
63629-1522-56362915220590 TABLET in 1 BOTTLE (63629-1522-5) 90 tablet2011-08-010000-00-00NoNoCurrent