Home NDC 43063-233 Amlodipine Besylate and Benazepril Hydrochloride
Product NDC 43063-233
11-digit product format 430630233
Labeler code 43063
Product ID 43063-233_9ec75fd5-2afd-41a8-b508-8f74ee20f8b1
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 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 · 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 43063-233-60 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 43063-233-60 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 43063-233-60 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 43063-233-60 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 43063-233-60 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 43063-233-60 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 43063-233-60 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 43063-233-60 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 43063-233-60 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 43063-233-60 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 43063-233-60 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 43063-233-60 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 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 BENAZEPRIL HYDROCHLORIDE ACTIVE INGREDIENT N1SN99T69T AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 AMLODIPINE ACTIVE MOIETY 1J444QC288 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 BENAZEPRIL ACTIVE MOIETY UDM7Q7QWP8 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 CALCIUM PHOSPHATE INACTIVE INGREDIENT 97Z1WI3NDX AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 1
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