Home NDC 69150-115-05 Amlodipine Besylate
Product NDC 69150-115
Requested package NDC 69150-115-05
11-digit product format 691500115
Labeler code 69150
Product ID 69150-115_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 10 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 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 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 · 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 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-11 84e616aacf4f…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…
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 69150-115-01 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 69150-115-03 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 69150-115-05 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 69150-115-10 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 69150-115-90 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 69150-115-01 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 69150-115-03 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 69150-115-05 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 69150-115-10 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 69150-115-90 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 69150-115-01 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 69150-115-03 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 69150-115-05 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 69150-115-10 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 69150-115-90 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 69150-115-01 Amlodipine Besylate 100 in 1 BOTTLE TABLET 100 6 69150-115-03 Amlodipine Besylate 300 in 1 BOTTLE TABLET 300 6 69150-115-05 Amlodipine Besylate 500 in 1 BOTTLE TABLET 500 6 69150-115-10 Amlodipine Besylate 1000 in 1 BOTTLE TABLET 1000 6 69150-115-90 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 69150-115 AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [BIOMES PHARMACEUTICALS LLC] 6 Legacy NDC, 5 package rows 20210116_829aad05-7f21-41c2-b80b-2da793ae70d7.zip
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 69150-115-05 69150011505 500 TABLET in 1 BOTTLE (69150-115-05) 500 tablet 2018-07-25 0000-00-00 No No Current