Home NDC 55289-039-30 Lotrel
Product NDC 55289-039
Requested package NDC 55289-039-30
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 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
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
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