Home NDC 65862-102-61 Amlodipine Besylate
Product NDC 65862-102
Requested package NDC 65862-102-61
11-digit product format 658620102
Labeler code 65862
Product ID 65862-102_7929af8c-f3da-4b86-8388-20bbe247336e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine Besylate
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA078021
Marketing category ANDA
Marketing start 2007-07-17
Substance AMLODIPINE BESYLATE
Active strength 5 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 · 21 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 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 5b2001dcd8f5…54b53d4dc9e4…
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 A078021-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-17 A078021-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-17 A078021-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-17
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 A078021-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078021-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078021-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078021-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078021-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078021-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078021-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078021-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078021-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078021-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078021-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078021-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078021-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078021-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078021-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078021-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078021-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078021-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078021-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078021-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078021-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078021-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078021-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078021-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078021-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078021-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078021-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078021-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078021-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078021-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078021-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078021-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078021-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078021-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078021-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078021-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078021-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078021-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078021-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078021-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-17 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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 5 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65862-102-05 Amlodipine Besylate 500 in 1 BOTTLE TABLET 500 20 65862-102-30 Amlodipine Besylate 30 in 1 BOTTLE TABLET 30 20 65862-102-90 Amlodipine Besylate 90 in 1 BOTTLE TABLET 90 20 65862-102-99 Amlodipine Besylate 1000 in 1 BOTTLE TABLET 1000 20
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-102 AMLODIPINE BESYLATE TABLET [AUROBINDO PHARMA LIMITED] 19 Current NDC, Legacy NDC, 4 package rows 20240426_b6f298ba-2d7e-4a3c-9edb-8b60aba716d6.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 Status 65862-102-61 65862010261 6000 TABLET in 1 BAG (65862-102-61) 6000 tablet 17-JUL-07 Current