Home NDC 42806-056 AMLODIPINE BESYLATE
Product NDC 42806-056
11-digit product format 428060056
Labeler code 42806
Product ID 42806-056_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 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 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMLODIPINE BESYLATE 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 42806-056-05 AMLODIPINE BESYLATE 500 in 1 BOTTLE TABLET 500 17 42806-056-09 AMLODIPINE BESYLATE 90 in 1 BOTTLE TABLET 90 17 42806-056-10 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 42806-056 AMLODIPINE BESYLATE TABLET [EPIC PHARMA, LLC] 16 Current NDC, Legacy NDC, 3 package rows 20231228_090f3e51-8129-4b5d-97f9-ab410e14df2d.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 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): 42806-056 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 42806-056-05 42806005605 500 TABLET in 1 BOTTLE (42806-056-05) 500 tablet 2011-04-25 0000-00-00 No No Current 42806-056-09 42806005609 90 TABLET in 1 BOTTLE (42806-056-09) 90 tablet 2011-04-25 0000-00-00 No No Current 42806-056-10 42806005610 1000 TABLET in 1 BOTTLE (42806-056-10) 1000 tablet 2011-04-25 0000-00-00 No No Current