Home NDC 68071-3246 Amlodipine besylate and benazepril hydrochloride
Product NDC 68071-3246
11-digit product format 680713246
Labeler code 68071
Product ID 68071-3246_5035d2a2-8386-118d-e054-00144ff88e88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine besylate and benazepril hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
Application ANDA077890
Marketing category ANDA
Marketing start 2010-10-13
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 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 4 of 5 · 176 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 2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 176 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.