Home NDC 59115-056 Amlodipine besylate
Product NDC 59115-056
11-digit product format 591150056
Labeler code 59115
Product ID 59115-056_1e1780ca-5513-49a7-9ee3-f27be5b2ccce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine besylate
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceutical
Application ANDA077771
Marketing category ANDA
Marketing start 2011-04-12
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 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 A077771-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2011-04-12 A077771-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2011-04-12 A077771-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2011-04-12
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 A077771-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2011-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077771-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2011-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077771-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2011-04-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077771-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077771-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077771-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2011-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077771-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077771-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077771-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2011-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077771-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2011-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077771-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2011-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077771-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2011-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077771-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2011-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077771-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2011-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077771-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2011-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077771-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2011-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077771-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2011-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077771-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2011-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077771-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2011-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077771-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2011-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077771-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2011-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077771-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2011-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077771-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2011-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077771-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2011-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077771-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2011-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077771-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2011-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077771-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2011-04-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077771-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2011-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077771-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2011-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077771-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2011-04-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077771-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2011-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077771-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2011-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077771-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2011-04-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077771-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2011-04-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077771-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2011-04-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077771-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2011-04-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077771-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2011-04-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077771-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2011-04-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077771-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2011-04-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077771-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2011-04-12 1e350fbaab3a…
Observed Orange Book normalized TE history#