Home NDC 52536-401 Enalapril maleate
Product NDC 52536-401
11-digit product format 525360401
Labeler code 52536
Product ID 52536-401_461e14b2-890d-011c-e063-6294a90a0d4c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Enalapril maleate
Dosage form SOLUTION
Route ORAL
Labeler Wilshire Pharmaceuticals, Inc.
Application NDA208686
Marketing category NDA
Marketing start 2024-04-08
Substance ENALAPRIL MALEATE
Active strength 1 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208686-001 EPANED ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N208686-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 17 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 2 · 42 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 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208686-001 EPANED 1MG/ML SOLUTION / ORAL RLD, RS 2016-09-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208686-001 EPANED 1MG/ML SOLUTION / ORAL RLD, RS 2016-09-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208686-001 EPANED 1MG/ML SOLUTION / ORAL RLD, RS 2016-09-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208686-001 EPANED 1MG/ML SOLUTION / ORAL RLD, RS 2016-09-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208686-001 EPANED 1MG/ML SOLUTION / ORAL RLD, RS 2016-09-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208686-001 EPANED 1MG/ML SOLUTION / ORAL RLD, RS 2016-09-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208686-001 EPANED 1MG/ML SOLUTION / ORAL RLD, RS 2016-09-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208686-001 EPANED 1MG/ML SOLUTION / ORAL RLD, RS 2016-09-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208686-001 EPANED 1MG/ML SOLUTION / ORAL AB RLD, RS 2016-09-20 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 17 · 680 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N208686-001 10039745 2036-03-25 Drug product 2018-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208686-001 10154987 2036-03-25 U-3 2019-01-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208686-001 10154987 2036-03-25 U-1892 2019-01-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208686-001 10154987 2036-03-25 U-185 2019-01-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208686-001 10154987 2036-03-25 U-71 2019-01-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208686-001 10154987 2036-03-25 U-1723 2019-01-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208686-001 10772868 2036-03-25 Drug product 2020-09-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208686-001 10786482 2036-03-25 Drug product 2020-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208686-001 11040023 2036-03-25 Drug product 2021-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208686-001 11141405 2036-03-25 Drug product 2021-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208686-001 11173141 2036-03-25 Drug product 2022-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208686-001 9669008 2036-03-25 Drug product 2017-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208686-001 9808442 2036-03-25 U-71 2017-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208686-001 9808442 2036-03-25 U-1723 2017-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208686-001 9808442 2036-03-25 U-185 2017-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208686-001 9808442 2036-03-25 U-1892 2017-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208686-001 9808442 2036-03-25 U-3 2017-11-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208686-001 10039745 2036-03-25 Drug product 2018-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208686-001 10154987 2036-03-25 U-3 2019-01-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208686-001 10154987 2036-03-25 U-1892 2019-01-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208686-001 10154987 2036-03-25 U-185 2019-01-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208686-001 10154987 2036-03-25 U-71 2019-01-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208686-001 10154987 2036-03-25 U-1723 2019-01-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208686-001 10772868 2036-03-25 Drug product 2020-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208686-001 10786482 2036-03-25 Drug product 2020-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208686-001 11040023 2036-03-25 Drug product 2021-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208686-001 11141405 2036-03-25 Drug product 2021-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208686-001 11173141 2036-03-25 Drug product 2022-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208686-001 9669008 2036-03-25 Drug product 2017-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208686-001 9808442 2036-03-25 U-71 2017-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208686-001 9808442 2036-03-25 U-1723 2017-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208686-001 9808442 2036-03-25 U-185 2017-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208686-001 9808442 2036-03-25 U-1892 2017-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208686-001 9808442 2036-03-25 U-3 2017-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208686-001 10039745 2036-03-25 Drug product 2018-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208686-001 10154987 2036-03-25 U-3 2019-01-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208686-001 10154987 2036-03-25 U-1892 2019-01-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208686-001 10154987 2036-03-25 U-185 2019-01-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208686-001 10154987 2036-03-25 U-71 2019-01-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208686-001 10154987 2036-03-25 U-1723 2019-01-04 31067a03dcf5…
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 1 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1435624 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 52536-401-01 Enalapril maleate 1 in 1 CARTON SOLUTION 1 2 52536-401-01 Enalapril maleate 150 mL in 1 BOTTLE SOLUTION 150 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52536-401 ENALAPRIL MALEATE SOLUTION [WILSHIRE PHARMACEUTICALS, INC.] 1 Current NDC, 2 package rows 20240413_c7934b45-eb6b-44c1-bd2c-ef0fa10850c1.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 52536-401-01 52536040101 1 BOTTLE in 1 CARTON (52536-401-01) / 150 mL in 1 BOTTLE 1 bottle 2024-04-08 No No Current