Home NDC 71610-620 AMLODIPINE BESYLATE
Product NDC 71610-620
11-digit product format 716100620
Labeler code 71610
Product ID 71610-620_1490fc40-2c20-dd29-e063-6294a90aed09
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMLODIPINE BESYLATE
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, 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 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 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 71610-620-30 AMLODIPINE BESYLATE 30 in 1 BOTTLE TABLET 30 2 71610-620-35 AMLODIPINE BESYLATE 35 in 1 BOTTLE TABLET 35 2 71610-620-45 AMLODIPINE BESYLATE 45 in 1 BOTTLE TABLET 45 2 71610-620-60 AMLODIPINE BESYLATE 90 in 1 BOTTLE TABLET 90 2 71610-620-80 AMLODIPINE BESYLATE 180 in 1 BOTTLE TABLET 180 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-620 AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Current NDC, Legacy NDC, 5 package rows 20240328_d17ef907-7719-4246-8ade-b67afdfaf787.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 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 ndc (product): 71610-620 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 71610-620-30 71610062030 30 TABLET in 1 BOTTLE (71610-620-30) 30 tablet 2021-01-10 0000-00-00 No No Current 71610-620-35 71610062035 35 TABLET in 1 BOTTLE (71610-620-35) 35 tablet 2021-01-10 0000-00-00 No No Current 71610-620-45 71610062045 45 TABLET in 1 BOTTLE (71610-620-45) 45 tablet 2022-01-18 0000-00-00 No No Current 71610-620-60 71610062060 90 TABLET in 1 BOTTLE (71610-620-60) 90 tablet 2021-12-02 0000-00-00 No No Current 71610-620-80 71610062080 180 TABLET in 1 BOTTLE (71610-620-80) 180 tablet 2021-12-02 0000-00-00 No No Current