Home NDC 55154-6875 Amlodipine Besylate
Product NDC 55154-6875
11-digit product format 551546875
Labeler code 55154
Product ID 55154-6875_3e9e049d-a988-4dc5-b9aa-14f1162409d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine Besylate
Dosage form TABLET
Route ORAL
Labeler Cardinal Health 107, LLC
Application ANDA078226
Marketing category ANDA
Marketing start 2013-01-20
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 A078226-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-09 A078226-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-09 A078226-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-09
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 A078226-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078226-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078226-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078226-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078226-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078226-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078226-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078226-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078226-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078226-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078226-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078226-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078226-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078226-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078226-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078226-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078226-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078226-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078226-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078226-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078226-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078226-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078226-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078226-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078226-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078226-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078226-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078226-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078226-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078226-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078226-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078226-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078226-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078226-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078226-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078226-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078226-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078226-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078226-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078226-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-09 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 · 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 55154-6875-0 Amlodipine Besylate 10 in 1 BAG TABLET 10 18 55154-6875-0 Amlodipine Besylate 1 in 1 BLISTER PACK TABLET 1 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-6875 AMLODIPINE BESYLATE TABLET [CARDINAL HEALTH 107, LLC] 16 Current NDC, Legacy NDC, 2 package rows 20250427_a74239bf-4684-424c-ba4e-6087e363265b.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 · 5 matching rows.
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 55154-6875-0 55154687500 10 BLISTER PACK in 1 BAG (55154-6875-0) / 1 TABLET in 1 BLISTER PACK 10 blister pack 2013-01-20 0000-00-00 No No Current