Home NDC 0615-1397 amlodipine besylate and benazepril hydrochloride
Product NDC 0615-1397
11-digit product format 006151397
Labeler code 0615
Product ID 0615-1397_d9910f83-8c88-4269-a518-60d97c2d4ff2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine besylate and benazepril hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application NDA020364
Marketing category NDA
Marketing start 1995-03-03
Marketing end 0000-00-00
Substance AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength 5 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 2017-12-31
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 0615-1397-39 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 0615-1397-39 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 0615-1397-39 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 0615-1397-39 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 0615-1397-39 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 0615-1397-39 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 0615-1397-39 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 0615-1397-39 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 0615-1397-39 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 0615-1397-39 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 0615-1397-39 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 0615-1397-39 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 0615-1397-39 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 0615-1397-39 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-1397-39 I Inactivated by FDA 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 264 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 2026-10-15 13:18:30 2026-09 N020364-002 LOTREL EQ 2.5MG BASE;10MG CAPSULE / ORAL RLD 1995-03-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020364-003 LOTREL EQ 5MG BASE;10MG CAPSULE / ORAL RLD 1995-03-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020364-004 LOTREL EQ 5MG BASE;20MG CAPSULE / ORAL RLD 1995-03-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020364-005 LOTREL EQ 10MG BASE;20MG CAPSULE / ORAL RLD 2002-06-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020364-006 LOTREL EQ 10MG BASE;40MG CAPSULE / ORAL RLD 2006-04-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020364-007 LOTREL EQ 5MG BASE;40MG CAPSULE / ORAL RLD 2006-04-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 N020364-002 LOTREL EQ 2.5MG BASE;10MG CAPSULE / ORAL RLD 1995-03-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020364-003 LOTREL EQ 5MG BASE;10MG CAPSULE / ORAL RLD 1995-03-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020364-004 LOTREL EQ 5MG BASE;20MG CAPSULE / ORAL RLD 1995-03-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020364-005 LOTREL EQ 10MG BASE;20MG CAPSULE / ORAL RLD 2002-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020364-006 LOTREL EQ 10MG BASE;40MG CAPSULE / ORAL RLD 2006-04-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020364-007 LOTREL EQ 5MG BASE;40MG CAPSULE / ORAL RLD 2006-04-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020364-002 LOTREL EQ 2.5MG BASE;10MG CAPSULE / ORAL RLD 1995-03-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020364-003 LOTREL EQ 5MG BASE;10MG CAPSULE / ORAL RLD 1995-03-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020364-004 LOTREL EQ 5MG BASE;20MG CAPSULE / ORAL RLD 1995-03-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020364-005 LOTREL EQ 10MG BASE;20MG CAPSULE / ORAL RLD 2002-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020364-006 LOTREL EQ 10MG BASE;40MG CAPSULE / ORAL RLD 2006-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020364-007 LOTREL EQ 5MG BASE;40MG CAPSULE / ORAL RLD 2006-04-11 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 6 · 240 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMLODIPINE BESYLATE ACTIVE INGREDIENT 864V2Q084H AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 BENAZEPRIL HYDROCHLORIDE ACTIVE INGREDIENT N1SN99T69T AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 AMLODIPINE ACTIVE MOIETY 1J444QC288 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 BENAZEPRILAT ACTIVE MOIETY JRM708L703 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 CALCIUM PHOSPHATE INACTIVE INGREDIENT 97Z1WI3NDX AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 GELATIN INACTIVE INGREDIENT 2G86QN327L AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 LACTOSE INACTIVE INGREDIENT J2B2A4N98G AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 TALC INACTIVE INGREDIENT 7SEV7J4R1U AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12