Home NDC 43489-101 Amlodipine Besylate
Product NDC 43489-101
11-digit product format 434890101
Labeler code 43489
Product ID 43489-101_53c969a7-d151-97a6-e063-6394a90ae408
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine Besylate
Dosage form TABLET
Route ORAL
Labeler China Resources Saike Pharmaceutical Co., Ltd.
Application ANDA090752
Marketing category ANDA
Marketing start 2016-05-16
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 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 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A090752-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2011-04-15 A090752-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2011-04-15 A090752-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-05-16
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 · 129 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 2026-09-14 22:38:34 2026-08 A090752-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2011-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090752-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2011-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090752-003 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-05-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090752-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2011-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090752-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2011-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090752-003 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-05-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090752-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2011-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090752-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2011-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090752-003 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090752-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2011-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090752-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2011-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090752-003 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090752-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2011-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090752-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2011-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090752-003 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090752-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2011-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090752-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2011-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090752-003 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090752-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2011-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090752-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2011-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090752-003 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090752-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2011-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090752-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2011-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090752-003 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090752-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2011-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090752-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2011-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090752-003 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090752-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2011-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090752-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2011-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090752-003 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090752-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2011-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090752-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2011-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090752-003 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090752-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2011-04-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090752-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2011-04-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090752-003 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090752-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2011-04-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090752-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2011-04-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090752-003 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2016-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090752-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2011-04-15 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 43489-101-01 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP. AMLODIPINE BESYLATE tablets, for oral adminstration Initial U.S. Approval: 1992 43489-101-01 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP. AMLODIPINE BESYLATE tablets, for oral adminstration Initial U.S. Approval: 1992 43489-101-03 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP. AMLODIPINE BESYLATE tablets, for oral adminstration Initial U.S. Approval: 1992 43489-101-03 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP. AMLODIPINE BESYLATE tablets, for oral adminstration Initial U.S. Approval: 1992 43489-101-05 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP. AMLODIPINE BESYLATE tablets, for oral adminstration Initial U.S. Approval: 1992 43489-101-05 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP. AMLODIPINE BESYLATE tablets, for oral adminstration Initial U.S. Approval: 1992
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43489-101-01 Amlodipine Besylate 90 in 1 BOTTLE, PLASTIC TABLET 90 24 43489-101-03 Amlodipine Besylate 500 in 1 BOTTLE, PLASTIC TABLET 500 24 43489-101-05 Amlodipine Besylate 1000 in 1 BOTTLE, PLASTIC TABLET 1000 24
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43489-101 AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [CHINA RESOURCES SAIKE PHARMACEUTICAL CO., LTD.] 24 Current NDC, Legacy NDC, 3 package rows 20210127_3518853a-4c5b-4161-a178-8da7f656f009.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 43489-101-01 43489010101 90 TABLET in 1 BOTTLE, PLASTIC (43489-101-01) 90 tablet 2016-05-23 0000-00-00 No No Current 43489-101-03 43489010103 500 TABLET in 1 BOTTLE, PLASTIC (43489-101-03) 500 tablet 2016-05-23 0000-00-00 No No Current 43489-101-05 43489010105 1000 TABLET in 1 BOTTLE, PLASTIC (43489-101-05) 1000 tablet 2016-05-23 0000-00-00 No No Current