Home NDC 72189-689 Amlodipine Besylate
Product NDC 72189-689
11-digit product format 721890689
Labeler code 72189
Product ID 72189-689_5c29aadb-b8fd-83c8-e063-6394a90a7a16
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine Besylate
Dosage form TABLET
Route ORAL
Labeler Direct_Rx
Application ANDA203245
Marketing category ANDA
Marketing start 2026-09-23
Substance AMLODIPINE BESYLATE
Active strength 2.5 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 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 A203245-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 A203245-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 A203245-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21
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 · 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 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 2.5 mg/1
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 2 of 2 · 21 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72189-689-90 72189068990 90 TABLET in 1 BOTTLE (72189-689-90) 90 tablet 2026-09-23 No No Current