Home NDC 16714-445 Enalapril Maleate
Product NDC 16714-445
11-digit product format 167140445
Labeler code 16714
Product ID 16714-445_4bc84994-0116-425c-8dab-ba08b0880b24
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name enalapril maleate
Dosage form TABLET
Route ORAL
Labeler Northstar RxLLC
Application ANDA075459
Marketing category ANDA
Marketing start 2015-08-06
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075459-001 ENALAPRIL MALEATE ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 A075459-002 ENALAPRIL MALEATE ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 84 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 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075459-001 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075459-002 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Enalapril Maleate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENALAPRIL MALEATE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9O25354EPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858804 Internal RxNorm lookup 858810 Internal RxNorm lookup 858813 Internal RxNorm lookup 858817 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16714-445-01 Enalapril Maleate 100 in 1 BOTTLE TABLET 100 9 16714-445-02 Enalapril Maleate 1000 in 1 BOTTLE TABLET 1000 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-445 ENALAPRIL MALEATE TABLET [NORTHSTAR RXLLC] 8 Current NDC, Legacy NDC, 2 package rows 20181212_e109e7b1-4650-4416-9d89-7c1185d5cf48.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16714-445-01 16714044501 100 TABLET in 1 BOTTLE (16714-445-01) 100 tablet 2015-08-06 0000-00-00 No No Current 16714-445-02 16714044502 1000 TABLET in 1 BOTTLE (16714-445-02) 1000 tablet 2015-08-06 0000-00-00 No No Current