Home NDC 69150-113-05 Amlodipine Besylate
Product NDC 69150-113
Requested package NDC 69150-113-05
11-digit product format 691500113
Labeler code 69150
Product ID 69150-113_f85efa7d-67e6-443a-bfca-f0c4a39af8f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine Besylate
Dosage form TABLET
Route ORAL
Labeler BIOMES PHARMACEUTICALS LLC
Application ANDA077516
Marketing category ANDA
Marketing start 2011-04-15
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 No
Listing certified through 2022-12-31
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 · 17 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2020-12-18 03:04 UTC · source 2020-12-17 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 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 A077516-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-11 A077516-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-11 A077516-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-11
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 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 69150-113-01 2023-01-30 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 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.<br><br>AMLODIPINE BESYL 69150-113-03 2023-01-30 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 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.<br><br>AMLODIPINE BESYL 69150-113-05 2023-01-30 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 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.<br><br>AMLODIPINE BESYL 69150-113-10 2023-01-30 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 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.<br><br>AMLODIPINE BESYL 69150-113-90 2023-01-30 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 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.<br><br>AMLODIPINE BESYL 69150-113-01 2021-01-15 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 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.<br><br>AMLODIPINE BESYL 69150-113-03 2021-01-15 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 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.<br><br>AMLODIPINE BESYL 69150-113-05 2021-01-15 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 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.<br><br>AMLODIPINE BESYL 69150-113-10 2021-01-15 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 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.<br><br>AMLODIPINE BESYL 69150-113-90 2021-01-15 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 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.<br><br>AMLODIPINE BESYL 69150-113-01 2020-01-31 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 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.<br><br>AMLODIPINE BESYL 69150-113-03 2020-01-31 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 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.<br><br>AMLODIPINE BESYL 69150-113-05 2020-01-31 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 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.<br><br>AMLODIPINE BESYL 69150-113-10 2020-01-31 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 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.<br><br>AMLODIPINE BESYL 69150-113-90 2020-01-31 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 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.<br><br>AMLODIPINE BESYL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69150-113-01 Amlodipine Besylate 100 in 1 BOTTLE TABLET 100 6 69150-113-03 Amlodipine Besylate 300 in 1 BOTTLE TABLET 300 6 69150-113-05 Amlodipine Besylate 500 in 1 BOTTLE TABLET 500 6 69150-113-10 Amlodipine Besylate 1000 in 1 BOTTLE TABLET 1000 6 69150-113-90 Amlodipine Besylate 90 in 1 BOTTLE TABLET 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69150-113 AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [BIOMES PHARMACEUTICALS LLC] 6 Legacy NDC, 5 package rows 20210116_829aad05-7f21-41c2-b80b-2da793ae70d7.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 69150-113-05 69150011305 500 TABLET in 1 BOTTLE (69150-113-05) 500 tablet 2018-07-25 0000-00-00 No No Current