Home NDC 70518-4197 Enalapril Maleate
Product NDC 70518-4197
11-digit product format 705184197
Labeler code 70518
Product ID 70518-4197_5a57ebd9-07fe-cfdf-e063-6294a90a98cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Enalapril Maleate
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA213273
Marketing category ANDA
Marketing start 2024-10-01
Substance ENALAPRIL MALEATE
Active strength 10 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A213273-001 ENALAPRIL MALEATE ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 A213273-002 ENALAPRIL MALEATE ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 A213273-003 ENALAPRIL MALEATE ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 A213273-004 ENALAPRIL MALEATE ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 · 116 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 2026-09-14 22:38:34 2026-08 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 116 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Enalapril Maleate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENALAPRIL MALEATE 10 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 70518-4197-0 Enalapril Maleate 90 in 1 BOTTLE, PLASTIC TABLET 90 4 70518-4197-1 Enalapril Maleate 30 in 1 BLISTER PACK TABLET 30 4 70518-4197-2 Enalapril Maleate 90 in 1 BOTTLE, PLASTIC TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4197 ENALAPRIL MALEATE TABLET [REMEDYREPACK INC.] 1 Current NDC, 3 package rows 20241004_5118eb9f-1466-4318-b17e-cf5898edbeef.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 2 of 2 · 21 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 70518-4197-0 70518419700 90 TABLET in 1 BOTTLE, PLASTIC (70518-4197-0) 90 tablet 2024-10-01 No No Current 70518-4197-1 70518419701 30 TABLET in 1 BLISTER PACK (70518-4197-1) 30 tablet 2025-05-03 No No Current 70518-4197-2 70518419702 90 TABLET in 1 BOTTLE, PLASTIC (70518-4197-2) 90 tablet 2025-07-13 No No Current