Home NDC 69238-1729 Enalapril Maleate
Product NDC 69238-1729
11-digit product format 692381729
Labeler code 69238
Product ID 69238-1729_4f8091c3-1233-48b9-a15e-e5da07c4272c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Enalapril
Dosage form SOLUTION
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA212894
Marketing category ANDA
Marketing start 2019-12-01
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 A212894-001 ENALAPRIL MALEATE ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212894-001 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 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL 2022-06-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL 2022-06-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL 2022-06-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL 2022-06-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL 2022-06-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL 2022-06-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL 2022-06-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL 2022-06-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL 2022-06-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL 2022-06-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212894-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2022-06-29 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 69238-1729-7 Enalapril Maleate 1 in 1 CARTON SOLUTION 1 9 69238-1729-7 Enalapril Maleate 150 mL in 1 BOTTLE SOLUTION 150 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1729 ENALAPRIL MALEATE (ENALAPRIL) SOLUTION [AMNEAL PHARMACEUTICALS NY LLC] 9 Current NDC, Legacy NDC, 2 package rows 20241023_e81a8aca-0e7c-4a02-b596-09e4ac22c70e.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 69238-1729-7 69238172907 1 BOTTLE in 1 CARTON (69238-1729-7) / 150 mL in 1 BOTTLE 1 bottle 2019-12-01 0000-00-00 No No Current