Home NDC 61919-813 ENALAPRIL MALEATE
Product NDC 61919-813
11-digit product format 619190813
Labeler code 61919
Product ID 61919-813_b1a82d7f-ada7-ecc5-e053-2995a90a089f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ENALAPRIL MALEATE
Dosage form TABLET
Route ORAL
Labeler DIRECT RX
Application NDA018998
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2019-04-30
Marketing end 0000-00-00
Substance ENALAPRIL MALEATE
Active strength 3 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 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61919-813-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61919-813-90 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61919-813-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61919-813-90 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61919-813-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61919-813-90 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61919-813-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61919-813-90 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61919-813-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61919-813-90 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61919-813-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61919-813-90 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61919-813-30 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61919-813-90 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61919-813-30 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61919-813-90 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61919-813-30 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61919-813-90 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N018998-001 VASOTEC ENALAPRIL MALEATE 5MG TABLET / ORAL AB RLD 1985-12-24 N018998-002 VASOTEC ENALAPRIL MALEATE 10MG TABLET / ORAL AB RLD 1985-12-24 N018998-003 VASOTEC ENALAPRIL MALEATE 20MG TABLET / ORAL AB RLD, RS 1985-12-24 N018998-005 VASOTEC ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB RLD 1988-07-26
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 5 · 168 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 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61919-813-30 ENALAPRIL MALEATE 30 in 1 BOTTLE TABLET 30 8 61919-813-90 ENALAPRIL MALEATE 90 in 1 BOTTLE TABLET 90 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-813 ENALAPRIL MALEATE TABLET [DIRECT RX] 8 Legacy NDC, 2 package rows 20230524_4984b255-e03b-0f7b-e054-00144ff88e88.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 · 3 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 61919-813-30 61919081330 30 TABLET in 1 BOTTLE (61919-813-30) 30 tablet 2019-04-30 0000-00-00 No No Current 61919-813-90 61919081390 90 TABLET in 1 BOTTLE (61919-813-90) 90 tablet 2019-04-30 0000-00-00 No No Current