Home NDC 0781-2279 Amlodipine Besylate and Benazepril Hydrochloride
Product NDC 0781-2279
11-digit product format 007812279
Labeler code 0781
Product ID 0781-2279_ee885922-cc1f-4cf5-89ff-43714520d1fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine besylate and benazepril hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Sandoz Inc
Application NDA020364
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1995-03-03
Marketing end 0000-00-00
Substance AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength 10 mg/1; mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag E
Listing certified through 2018-12-31
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 · 30 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 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0781-2279-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0781-2279-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0781-2279-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0781-2279-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0781-2279-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0781-2279-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0781-2279-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0781-2279-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0781-2279-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0781-2279-01 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0781-2279-01 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0781-2279-01 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0781-2279-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0781-2279-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0781-2279-01 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020364-002 LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL RLD 1995-03-03 N020364-003 LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL RLD 1995-03-03 N020364-004 LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL RLD 1995-03-03 N020364-005 LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL RLD 2002-06-20 N020364-006 LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL RLD 2006-04-11 N020364-007 LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL RLD 2006-04-11
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 7 · 246 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 2026-02-19 14:30 UTC 2026-02 N020364-002 LOTREL EQ 2.5MG BASE;10MG CAPSULE / ORAL AB RLD 1995-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020364-003 LOTREL EQ 5MG BASE;10MG CAPSULE / ORAL AB RLD 1995-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020364-004 LOTREL EQ 5MG BASE;20MG CAPSULE / ORAL AB RLD 1995-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020364-005 LOTREL EQ 10MG BASE;20MG CAPSULE / ORAL AB RLD 2002-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020364-006 LOTREL EQ 10MG BASE;40MG CAPSULE / ORAL AB RLD, RS 2006-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020364-007 LOTREL EQ 5MG BASE;40MG CAPSULE / ORAL AB RLD 2006-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020364-002 LOTREL EQ 2.5MG BASE;10MG CAPSULE / ORAL AB RLD 1995-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020364-003 LOTREL EQ 5MG BASE;10MG CAPSULE / ORAL AB RLD 1995-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020364-004 LOTREL EQ 5MG BASE;20MG CAPSULE / ORAL AB RLD 1995-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020364-005 LOTREL EQ 10MG BASE;20MG CAPSULE / ORAL AB RLD 2002-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020364-006 LOTREL EQ 10MG BASE;40MG CAPSULE / ORAL AB RLD, RS 2006-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020364-007 LOTREL EQ 5MG BASE;40MG CAPSULE / ORAL AB RLD 2006-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020364-002 LOTREL EQ 2.5MG BASE;10MG CAPSULE / ORAL AB RLD 1995-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020364-003 LOTREL EQ 5MG BASE;10MG CAPSULE / ORAL AB RLD 1995-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020364-004 LOTREL EQ 5MG BASE;20MG CAPSULE / ORAL AB RLD 1995-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020364-005 LOTREL EQ 10MG BASE;20MG CAPSULE / ORAL AB RLD 2002-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020364-006 LOTREL EQ 10MG BASE;40MG CAPSULE / ORAL AB RLD, RS 2006-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020364-007 LOTREL EQ 5MG BASE;40MG CAPSULE / ORAL AB RLD 2006-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020364-002 LOTREL EQ 2.5MG BASE;10MG CAPSULE / ORAL AB RLD 1995-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020364-003 LOTREL EQ 5MG BASE;10MG CAPSULE / ORAL AB RLD 1995-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020364-004 LOTREL EQ 5MG BASE;20MG CAPSULE / ORAL AB RLD 1995-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020364-005 LOTREL EQ 10MG BASE;20MG CAPSULE / ORAL AB RLD 2002-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020364-006 LOTREL EQ 10MG BASE;40MG CAPSULE / ORAL AB RLD, RS 2006-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020364-007 LOTREL EQ 5MG BASE;40MG CAPSULE / ORAL AB RLD 2006-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020364-002 LOTREL EQ 2.5MG BASE;10MG CAPSULE / ORAL AB RLD 1995-03-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020364-003 LOTREL EQ 5MG BASE;10MG CAPSULE / ORAL AB RLD 1995-03-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020364-004 LOTREL EQ 5MG BASE;20MG CAPSULE / ORAL AB RLD 1995-03-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020364-005 LOTREL EQ 10MG BASE;20MG CAPSULE / ORAL AB RLD 2002-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020364-006 LOTREL EQ 10MG BASE;40MG CAPSULE / ORAL AB RLD, RS 2006-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020364-007 LOTREL EQ 5MG BASE;40MG CAPSULE / ORAL AB RLD 2006-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020364-002 LOTREL EQ 2.5MG BASE;10MG CAPSULE / ORAL AB RLD 1995-03-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020364-003 LOTREL EQ 5MG BASE;10MG CAPSULE / ORAL AB RLD 1995-03-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020364-004 LOTREL EQ 5MG BASE;20MG CAPSULE / ORAL AB RLD 1995-03-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020364-005 LOTREL EQ 10MG BASE;20MG CAPSULE / ORAL AB RLD 2002-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020364-006 LOTREL EQ 10MG BASE;40MG CAPSULE / ORAL AB RLD, RS 2006-04-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020364-007 LOTREL EQ 5MG BASE;40MG CAPSULE / ORAL AB RLD 2006-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020364-002 LOTREL EQ 2.5MG BASE;10MG CAPSULE / ORAL AB RLD 1995-03-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020364-003 LOTREL EQ 5MG BASE;10MG CAPSULE / ORAL AB RLD 1995-03-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020364-004 LOTREL EQ 5MG BASE;20MG CAPSULE / ORAL AB RLD 1995-03-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020364-005 LOTREL EQ 10MG BASE;20MG CAPSULE / ORAL AB RLD 2002-06-20 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 240 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lotrel AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE Novartis Pharmaceuticals Corporation 94ae6054-b7ae-4212-a567-4f803af8f2c7 2023-08-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020364 application number: NDA020364
DailyMed RxNorm Mappings#