Home NDC 68645-580 AMLODIPINE BESYLATE
Product NDC 68645-580
11-digit product format 686450580
Labeler code 68645
Product ID 68645-580_4c219dee-9f8c-6c56-e063-6294a90accf8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMLODIPINE BESYLATE
Dosage form TABLET
Route ORAL
Labeler Legacy Pharmaceutical Packaging, LLC
Application ANDA078552
Marketing category ANDA
Marketing start 2011-04-25
Substance AMLODIPINE BESYLATE
Active strength 10 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A078552-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2009-04-08 A078552-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2009-04-08 A078552-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2009-04-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 2026-08-18 06:07:40 2026-07 A078552-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2009-04-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078552-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2009-04-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078552-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2009-04-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078552-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2009-04-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078552-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2009-04-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078552-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2009-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078552-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2009-04-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078552-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2009-04-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078552-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2009-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078552-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2009-04-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078552-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2009-04-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078552-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2009-04-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078552-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2009-04-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078552-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2009-04-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078552-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2009-04-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078552-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2009-04-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078552-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2009-04-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078552-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2009-04-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078552-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2009-04-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078552-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2009-04-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078552-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2009-04-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078552-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2009-04-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078552-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2009-04-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078552-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2009-04-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078552-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2009-04-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078552-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2009-04-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078552-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2009-04-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078552-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2009-04-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078552-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2009-04-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078552-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2009-04-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078552-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2009-04-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078552-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2009-04-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078552-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2009-04-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078552-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2009-04-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078552-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2009-04-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078552-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2009-04-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078552-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2009-04-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078552-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2009-04-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078552-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2009-04-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078552-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2009-04-08 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base AMLODIPINE BESYLATE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMLODIPINE BESYLATE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864V2Q084H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308135 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68645-580-54 AMLODIPINE BESYLATE 30 in 1 BOTTLE TABLET 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68645-580 AMLODIPINE BESYLATE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20250308_215ef2cb-d5b6-43d5-bbd5-195ec57cde2b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AMLODIPINE BESYLATE AMLODIPINE BESYLATE Legacy Pharmaceutical Packaging, LLC 215ef2cb-d5b6-43d5-bbd5-195ec57cde2b 2026-03-03 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078552 application number: ANDA078552 ndc (product): 68645-580 AMLODIPINE BESYLATE AMLODIPINE BESYLATE Epic Pharma, LLC 090f3e51-8129-4b5d-97f9-ab410e14df2d 2025-12-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078552 application number: ANDA078552 AMLODIPINE BESYLATE AMLODIPINE BESYLATE Aphena Pharma Solutions - Tennessee, LLC d17ef907-7719-4246-8ade-b67afdfaf787 2024-03-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078552 application number: ANDA078552 AMLODIPINE BESYLATE AMLODIPINE BESYLATE Aphena Pharma Solutions - Tennessee, LLC 186b6149-9610-4380-9bf2-941646069276 2023-05-04 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078552 application number: ANDA078552
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68645-580-54 68645058054 30 TABLET in 1 BOTTLE (68645-580-54) 30 tablet 2011-04-25 0000-00-00 No No Current