Home NDC 52605-041 amlodipine besylate
Product NDC 52605-041
11-digit product format 526050041
Labeler code 52605
Product ID 52605-041_83e3e459-c254-45e3-a5ac-2e717e08c348
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine besylate
Dosage form TABLET
Route ORAL
Labeler POLYGEN PHARMACEUTICALS INC.
Application ANDA207821
Marketing category ANDA
Marketing start 2016-07-11
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 52605-041 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 52605-041 52605-041-19 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 52605-041 52605-041-10 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
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 A207821-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-07-11 A207821-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2016-07-11 A207821-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2016-07-11
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 A207821-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207821-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2016-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207821-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2016-07-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207821-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207821-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2016-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207821-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2016-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207821-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207821-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2016-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207821-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2016-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207821-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207821-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2016-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207821-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2016-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207821-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207821-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2016-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207821-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2016-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207821-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207821-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2016-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207821-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2016-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207821-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207821-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2016-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207821-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2016-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207821-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207821-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2016-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207821-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2016-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207821-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207821-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2016-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207821-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2016-07-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207821-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207821-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2016-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207821-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2016-07-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207821-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-07-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207821-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2016-07-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207821-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2016-07-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207821-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-07-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207821-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2016-07-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207821-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2016-07-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207821-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-07-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207821-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2016-07-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207821-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2016-07-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207821-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-07-11 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 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52605-041-10 amlodipine besylate 1000 in 1 BOTTLE TABLET 1000 8 52605-041-19 amlodipine besylate 90 in 1 BOTTLE TABLET 90 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52605-041 AMLODIPINE BESYLATE TABLET [POLYGEN PHARMACEUTICALS INC.] 8 Current NDC, Legacy NDC, 2 package rows 20221130_f5fbfd12-a600-482d-a306-5d6c09ae4210.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 · 1 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 52605-041-10 52605004110 1000 TABLET in 1 BOTTLE (52605-041-10) 1000 tablet 2016-07-11 0000-00-00 No No Current 52605-041-19 52605004119 90 TABLET in 1 BOTTLE (52605-041-19) 90 tablet 2016-07-11 0000-00-00 No No Current