Home NDC 63187-370 Amlodipine Besylate and Benazepril Hydrochloride
Product NDC 63187-370
11-digit product format 631870370
Labeler code 63187
Product ID 63187-370_5a9f4cba-fb80-4001-811a-2fcff0408b16
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine Besylate and Benazepril Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Proficient Rx LP
Application ANDA090364
Marketing category ANDA
Marketing start 2011-07-05
Marketing end 0000-00-00
Substance AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength 10 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 No
Listing certified through 2020-12-31
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A090364-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 A090364-002 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 · 88 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 A090364-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090364-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090364-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090364-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090364-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090364-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090364-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090364-002 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 A090364-001 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 A090364-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090364-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090364-002 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 A090364-001 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 A090364-002 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 A090364-001 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 A090364-002 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 A090364-001 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 A090364-002 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 A090364-001 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 A090364-002 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 A090364-001 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 A090364-002 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 A090364-001 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 A090364-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090364-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090364-002 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 A090364-001 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 A090364-002 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 A090364-001 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 A090364-002 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 A090364-001 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 A090364-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090364-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090364-002 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 A090364-001 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 A090364-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090364-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090364-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090364-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090364-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE / ORAL AB 2011-07-05 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.