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 3 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 2019-12-13 00:20 UTC 2019-12 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077890-001 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A077890-002 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE / ORAL AB 2010-10-14 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A077890-003 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A077890-004 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE / ORAL AB 2010-10-14 ea99ee380514…
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.