Home NDC 65162-007-03 Amlodipine Besylate
Product NDC 65162-007
Requested package NDC 65162-007-03
11-digit product format 651620007
Labeler code 65162
Product ID 65162-007_4d860e50-5f2c-4c8e-a18e-737825e41022
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine Besylate
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA078477
Marketing category ANDA
Marketing start 2010-06-21
Marketing end 0000-00-00
Substance AMLODIPINE BESYLATE
Active strength 5 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 65162-007 65162-007-03 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 A078477-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2008-01-16 A078477-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2008-01-16 A078477-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2008-01-16
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 A078477-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2008-01-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078477-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2008-01-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078477-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2008-01-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078477-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2008-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078477-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2008-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078477-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2008-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078477-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2008-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078477-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2008-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078477-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2008-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078477-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2008-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078477-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2008-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078477-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2008-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078477-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2008-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078477-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2008-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078477-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2008-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078477-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2008-01-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078477-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2008-01-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078477-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2008-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078477-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2008-01-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078477-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2008-01-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078477-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2008-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078477-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2008-01-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078477-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2008-01-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078477-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2008-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078477-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2008-01-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078477-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2008-01-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078477-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2008-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078477-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2008-01-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078477-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2008-01-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078477-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2008-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078477-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2008-01-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078477-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2008-01-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078477-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2008-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078477-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2008-01-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078477-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2008-01-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078477-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2008-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078477-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2008-01-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078477-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2008-01-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078477-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2008-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078477-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2008-01-16 301d65b070ca…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMLODIPINE BESYLATE ACTIVE INGREDIENT 864V2Q084H AMLODIPINE BESYLATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 24 AMLODIPINE ACTIVE MOIETY 1J444QC288 AMLODIPINE BESYLATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 24 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J AMLODIPINE BESYLATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 24 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMLODIPINE BESYLATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 24 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMLODIPINE BESYLATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 24 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMLODIPINE BESYLATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 24
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-007 AMLODIPINE BESYLATE TABLET [AMNEAL PHARMACEUTICALS LLC] 36 Legacy NDC 20241025_3d14c6b5-a70a-477f-b332-fa5b93a6296f.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65162-007-03 65162000703 30 TABLET in 1 BOTTLE (65162-007-03) 30 tablet 2010-06-21 0000-00-00 No No Current