Home NDC 10135-761-10 amlodipine besylate
Product NDC 10135-761
Requested package NDC 10135-761-10
11-digit product format 101350761
Labeler code 10135
Product ID 10135-761_eb82ef86-51fa-dd36-e053-2a95a90aa5eb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine besylate
Dosage form TABLET
Route ORAL
Labeler Marlex Pharmaceuticals, Inc.
Application ANDA207821
Marketing category ANDA
Marketing start 2022-10-01
Marketing end 0000-00-00
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 2023-12-31
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 · 15 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…
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.
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 10135-761-10 amlodipine besylate 1000 in 1 BOTTLE TABLET 1000 1 10135-761-90 amlodipine besylate 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-761 AMLODIPINE BESYLATE TABLET [MARLEX PHARMACEUTICALS, INC.] 1 Legacy NDC, 2 package rows 20221021_eb82ef86-51f9-dd36-e053-2a95a90aa5eb.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 10135-761-10 10135076110 1000 TABLET in 1 BOTTLE (10135-761-10) 1000 tablet 2022-10-01 0000-00-00 No No Current