Home NDC 42806-055 AMLODIPINE BESYLATE
Product NDC 42806-055
11-digit product format 428060055
Labeler code 42806
Product ID 42806-055_ea20d1c2-78a5-4674-b2c2-f74e9fdcdf28
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMLODIPINE BESYLATE
Dosage form TABLET
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA078552
Marketing category ANDA
Marketing start 2011-04-25
Substance AMLODIPINE BESYLATE
Active strength 2.5 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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 123 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 2026-02-19 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…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078552-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2009-04-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078552-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2009-04-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078552-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2009-04-08 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 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 ndc (product): 42806-055 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
Additional Listing Data#
Finished product Yes
Brand name base AMLODIPINE BESYLATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMLODIPINE BESYLATE 2.5 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197361 Internal RxNorm lookup 308135 Internal RxNorm lookup 308136 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 42806-055-05 AMLODIPINE BESYLATE 500 in 1 BOTTLE TABLET 500 17 42806-055-09 AMLODIPINE BESYLATE 90 in 1 BOTTLE TABLET 90 17 42806-055-10 AMLODIPINE BESYLATE 1000 in 1 BOTTLE TABLET 1000 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMLODIPINE BESYLATE ACTIVE INGREDIENT 864V2Q084H AMLODIPINE BESYLATE TABLET [EPIC PHARMA, LLC] 8 AMLODIPINE ACTIVE MOIETY 1J444QC288 AMLODIPINE BESYLATE TABLET [EPIC PHARMA, LLC] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMLODIPINE BESYLATE TABLET [EPIC PHARMA, LLC] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMLODIPINE BESYLATE TABLET [EPIC PHARMA, LLC] 8 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMLODIPINE BESYLATE TABLET [EPIC PHARMA, LLC] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AMLODIPINE BESYLATE TABLET [EPIC PHARMA, LLC] 8 AMLODIPINE BESYLATE ACTIVE INGREDIENT 864V2Q084H AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [AVPAK] 2 AMLODIPINE ACTIVE MOIETY 1J444QC288 AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [AVPAK] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [AVPAK] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [AVPAK] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [AVPAK] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [AVPAK] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-055 AMLODIPINE BESYLATE TABLET [EPIC PHARMA, LLC] 16 Current NDC, Legacy NDC, 3 package rows 20231228_090f3e51-8129-4b5d-97f9-ab410e14df2d.zip
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 42806-055-05 42806005505 500 TABLET in 1 BOTTLE (42806-055-05) 500 tablet 2011-04-25 0000-00-00 No No Current 42806-055-09 42806005509 90 TABLET in 1 BOTTLE (42806-055-09) 90 tablet 2011-04-25 0000-00-00 No No Current 42806-055-10 42806005510 1000 TABLET in 1 BOTTLE (42806-055-10) 1000 tablet 2011-04-25 0000-00-00 No No Current