Home NDC 0378-1052 Enalapril Maleate
Product NDC 0378-1052
11-digit product format 003781052
Labeler code 0378
Product ID 0378-1052_62025f28-0d2f-45c7-9e22-010086ff1bb0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Enalapril Maleate
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA075480
Marketing category ANDA
Marketing start 2000-08-22
Marketing end 2019-04-30
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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075480-001 ENALAPRIL MALEATE ENALAPRIL MALEATE 2.5MG TABLET / ORAL 2000-08-22 A075480-002 ENALAPRIL MALEATE ENALAPRIL MALEATE 5MG TABLET / ORAL 2000-08-22 A075480-003 ENALAPRIL MALEATE ENALAPRIL MALEATE 10MG TABLET / ORAL 2000-08-22 A075480-004 ENALAPRIL MALEATE ENALAPRIL MALEATE 20MG TABLET / ORAL 2000-08-22
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A075480-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL 2000-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075480-002 ENALAPRIL MALEATE 5MG TABLET / ORAL 2000-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075480-003 ENALAPRIL MALEATE 10MG TABLET / ORAL 2000-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075480-004 ENALAPRIL MALEATE 20MG TABLET / ORAL 2000-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075480-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL 2000-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075480-002 ENALAPRIL MALEATE 5MG TABLET / ORAL 2000-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075480-003 ENALAPRIL MALEATE 10MG TABLET / ORAL 2000-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075480-004 ENALAPRIL MALEATE 20MG TABLET / ORAL 2000-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075480-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL 2000-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075480-002 ENALAPRIL MALEATE 5MG TABLET / ORAL 2000-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075480-003 ENALAPRIL MALEATE 10MG TABLET / ORAL 2000-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075480-004 ENALAPRIL MALEATE 20MG TABLET / ORAL 2000-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075480-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL 2000-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075480-002 ENALAPRIL MALEATE 5MG TABLET / ORAL 2000-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075480-003 ENALAPRIL MALEATE 10MG TABLET / ORAL 2000-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075480-004 ENALAPRIL MALEATE 20MG TABLET / ORAL 2000-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075480-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL 2000-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075480-002 ENALAPRIL MALEATE 5MG TABLET / ORAL 2000-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075480-003 ENALAPRIL MALEATE 10MG TABLET / ORAL 2000-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075480-004 ENALAPRIL MALEATE 20MG TABLET / ORAL 2000-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075480-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL 2000-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075480-002 ENALAPRIL MALEATE 5MG TABLET / ORAL 2000-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075480-003 ENALAPRIL MALEATE 10MG TABLET / ORAL 2000-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075480-004 ENALAPRIL MALEATE 20MG TABLET / ORAL 2000-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075480-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL 2000-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075480-002 ENALAPRIL MALEATE 5MG TABLET / ORAL 2000-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075480-003 ENALAPRIL MALEATE 10MG TABLET / ORAL 2000-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075480-004 ENALAPRIL MALEATE 20MG TABLET / ORAL 2000-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075480-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL 2000-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075480-002 ENALAPRIL MALEATE 5MG TABLET / ORAL 2000-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075480-003 ENALAPRIL MALEATE 10MG TABLET / ORAL 2000-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075480-004 ENALAPRIL MALEATE 20MG TABLET / ORAL 2000-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075480-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL 2000-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075480-002 ENALAPRIL MALEATE 5MG TABLET / ORAL 2000-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075480-003 ENALAPRIL MALEATE 10MG TABLET / ORAL 2000-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075480-004 ENALAPRIL MALEATE 20MG TABLET / ORAL 2000-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075480-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL 2000-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075480-002 ENALAPRIL MALEATE 5MG TABLET / ORAL 2000-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075480-003 ENALAPRIL MALEATE 10MG TABLET / ORAL 2000-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075480-004 ENALAPRIL MALEATE 20MG TABLET / ORAL 2000-08-22 d8e5a09893c0…
DailyMed Socrata Ingredients#