Home NDC 63629-1525-4 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
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075483-001 ENALAPRIL MALEATE ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 A075483-002 ENALAPRIL MALEATE ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 A075483-003 ENALAPRIL MALEATE ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 A075483-004 ENALAPRIL MALEATE ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-1525 ENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK] 1006 Legacy NDC 20230602_3f9d11af-24e3-423c-9f82-e7aca1010ce9.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-1525-4 63629152504 90 TABLET in 1 BOTTLE (63629-1525-4) 90 tablet 2009-12-11 0000-00-00 No No Current