Home NDC 59651-529 ENALAPRIL MALEATE
Product NDC 59651-529
11-digit product format 596510529
Labeler code 59651
Product ID 59651-529_2b0fd0eb-c717-4d3d-8c1a-5445bf64a7a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ENALAPRIL MALEATE
Dosage form SOLUTION
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA216458
Marketing category ANDA
Marketing start 2024-01-08
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 A216458-001 ENALAPRIL MALEATE ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216458-001 AB
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.
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 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 a50c72e98297…
Observed Orange Book normalized TE history# 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 59651-529-55 ENALAPRIL MALEATE 1 in 1 CARTON SOLUTION 1 2 59651-529-55 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 59651-529 ENALAPRIL MALEATE SOLUTION [AUROBINDO PHARMA LIMITED] 2 Current NDC, 2 package rows 20240124_337707cc-4ed9-4121-bfff-c5015e5eca9d.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 Sample Exclude flag Status 59651-529-55 59651052955 1 BOTTLE in 1 CARTON (59651-529-55) / 150 mL in 1 BOTTLE 1 bottle 2024-01-08 No No Current