Home NDC 53808-0653 Amlodipine Besylate
Product NDC 53808-0653
11-digit product format 538080653
Labeler code 53808
Product ID 53808-0653_24efe210-73f3-446c-a8d3-88baa1508702
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine besylate
Dosage form TABLET
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application ANDA076418
Marketing category ANDA
Marketing start 2009-07-01
Marketing end 0000-00-00
Substance AMLODIPINE BESYLATE
Active strength 3 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53808-0653-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53808-0653-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53808-0653-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53808-0653-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53808-0653-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53808-0653-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53808-0653-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53808-0653-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53808-0653-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53808-0653-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53808-0653-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53808-0653-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53808-0653-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53808-0653-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53808-0653-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53808-0653-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53808-0653-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53808-0653-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53808-0653-1 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53808-0653-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53808-0653-1 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53808-0653-1 110d247fa046…a55b01930146…
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 A076418-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2005-10-03 A076418-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2005-10-03 A076418-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2005-10-03
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 3 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 2019-12-14 00:12 UTC 2019-12 A076418-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2005-10-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076418-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2005-10-03 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A076418-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2005-10-03 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A076418-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2005-10-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076418-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2005-10-03 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A076418-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2005-10-03 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A076418-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2005-10-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076418-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2005-10-03 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076418-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2005-10-03 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076418-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2005-10-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076418-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2005-10-03 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A076418-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2005-10-03 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A076418-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2005-10-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076418-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2005-10-03 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A076418-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2005-10-03 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A076418-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2005-10-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076418-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2005-10-03 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076418-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2005-10-03 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076418-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2005-10-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076418-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2005-10-03 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076418-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2005-10-03 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076418-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2005-10-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076418-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2005-10-03 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076418-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2005-10-03 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076418-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2005-10-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076418-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2005-10-03 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076418-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2005-10-03 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076418-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2005-10-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076418-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2005-10-03 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A076418-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2005-10-03 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A076418-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2005-10-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076418-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2005-10-03 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A076418-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2005-10-03 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A076418-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2005-10-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076418-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2005-10-03 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076418-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2005-10-03 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076418-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2005-10-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076418-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2005-10-03 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A076418-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2005-10-03 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A076418-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2005-10-03 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 53808-0653-1 Amlodipine Besylate 30 in 1 BLISTER PACK TABLET 30 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-0653 AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 4 Legacy NDC, 1 package rows 20100824_a10fa641-ac6b-466d-bcba-31c678a74be8.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-0653-1 53808065301 30 in 1 BLISTER PACK Historical