Home NDC 64679-423 Amlodipine Besylate
Product NDC 64679-423
11-digit product format 646790423
Labeler code 64679
Product ID 64679-423_ca52537d-f250-4092-9033-960674a43410
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine Besylate
Dosage form TABLET
Route ORAL
Labeler Wockhardt USA LLC.
Application ANDA078500
Marketing category ANDA
Marketing start 2007-09-06
Marketing end 0000-00-00
Substance AMLODIPINE BESYLATE
Active strength 10 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag No
Listing certified through 2019-12-31
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 2 · 105 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-423-03 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-423-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-423-04 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-423-02 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-423-03 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-423-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-423-04 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-423-02 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-423-03 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-423-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-423-04 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-423-02 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-423-03 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-423-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-423-04 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-423-02 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-423-03 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-423-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-423-04 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-423-02 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-423-03 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-423-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-423-04 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-423-02 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-423-03 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-423-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-423-04 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-423-02 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-423-03 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-423-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-423-04 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-423-02 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-423-03 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-423-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-423-04 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-423-02 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-423-03 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-423-01 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-423-04 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-423-02 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-423-02 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-423-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-423-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-423-04 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-423-02 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-423-03 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-423-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-423-04 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078500-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-09-06 A078500-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-09-06 A078500-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-09-06
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 4 · 129 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 A078500-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-09-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078500-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-09-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078500-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-09-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078500-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-09-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078500-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-09-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078500-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-09-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078500-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078500-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078500-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-09-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078500-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078500-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078500-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-09-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078500-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078500-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078500-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-09-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078500-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-09-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078500-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-09-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078500-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-09-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078500-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-09-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078500-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-09-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078500-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-09-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078500-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-09-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078500-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-09-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078500-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-09-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078500-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-09-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078500-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-09-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078500-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-09-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078500-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-09-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078500-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-09-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078500-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-09-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078500-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-09-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078500-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-09-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078500-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-09-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078500-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-09-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078500-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-09-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078500-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-09-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078500-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-09-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078500-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-09-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078500-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-09-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078500-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-09-06 301d65b070ca…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 64679-423-01 2024-10-24 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 64679-423-02 2024-10-24 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 64679-423-03 2024-10-24 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 64679-423-04 2024-10-24 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 64679-423-01 2020-01-31 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 64679-423-02 2020-01-31 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 64679-423-03 2020-01-31 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 64679-423-04 2020-01-31 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
DailyMed Socrata Ingredients#