Home NDC 70518-4388-0 Amlodipine Besylate and Benazepril Hydrochloride
Product NDC 70518-4388
Requested package NDC 70518-4388-0
11-digit product format 705184388
Labeler code 70518
Product ID 70518-4388_5b11a3df-aa7d-b31e-e063-6394a90ab2b2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine Besylate and Benazepril Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA090149
Marketing category ANDA
Marketing start 2025-07-06
Substance AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength 5; 40 mg/1; mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 86 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 2026-09-14 22:38:34 2026-08 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090149-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090149-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Amlodipine Besylate and Benazepril Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMLODIPINE BESYLATE 5 mg/1 BENAZEPRIL HYDROCHLORIDE 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864V2Q084H Internal UNII lookup N1SN99T69T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 898359 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-4388-0 Amlodipine Besylate and Benazepril Hydrochloride 90 in 1 BOTTLE, PLASTIC CAPSULE 90 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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4388-0 70518438800 90 CAPSULE in 1 BOTTLE, PLASTIC (70518-4388-0) 90 capsule 2025-07-06 No No Current