Home NDC 55289-039 Lotrel
Product NDC 55289-039
11-digit product format 552890039
Labeler code 55289
Product ID 55289-039_dcf4c306-c361-5b34-e053-2a95a90a824b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine besylate and benazepril hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
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 Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55289-039-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55289-039-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55289-039-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55289-039-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55289-039-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55289-039-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55289-039-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55289-039-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55289-039-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55289-039-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55289-039-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55289-039-30 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMLODIPINE BESYLATE ACTIVE INGREDIENT 864V2Q084H LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 BENAZEPRIL HYDROCHLORIDE ACTIVE INGREDIENT N1SN99T69T LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 AMLODIPINE ACTIVE MOIETY 1J444QC288 LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 BENAZEPRILAT ACTIVE MOIETY JRM708L703 LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 CALCIUM PHOSPHATE INACTIVE INGREDIENT 97Z1WI3NDX LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 GELATIN INACTIVE INGREDIENT 2G86QN327L LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 LACTOSE INACTIVE INGREDIENT J2B2A4N98G LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 TALC INACTIVE INGREDIENT 7SEV7J4R1U LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55289-039-30 55289003930 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-039-30) 30 capsule 2011-10-10 0000-00-00 No No Current