Home NDC 64980-723 Amlodipine Besylate
Product NDC 64980-723
11-digit product format 649800723
Labeler code 64980
Product ID 64980-723_01b46020-bf09-4338-9dd9-c0d6202c943a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine Besylate
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA201380
Marketing category ANDA
Marketing start 2026-07-20
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 44 .
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 A201380-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2012-04-13 A201380-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2012-04-13 A201380-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2026-02-17
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 3 · 92 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 2026-10-15 13:18:30 2026-09 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2012-04-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2012-04-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A201380-003 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2026-02-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2012-04-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2012-04-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201380-003 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2026-02-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2012-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2012-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201380-003 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2026-02-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2012-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2012-04-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2012-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2012-04-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2012-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2012-04-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2012-04-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2012-04-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2012-04-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2012-04-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2012-04-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2012-04-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2012-04-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2012-04-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2012-04-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2012-04-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2012-04-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2012-04-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2012-04-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2012-04-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2012-04-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2012-04-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2012-04-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2012-04-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2012-04-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2012-04-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2012-04-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2012-04-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2012-04-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201380-002 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2012-04-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201380-001 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2012-04-13 5d02ea3f76ae…
Observed Orange Book normalized TE history# 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64980-723-09 64980072309 90 TABLET in 1 BOTTLE (64980-723-09) 90 tablet 2026-07-20 No No Current 64980-723-10 64980072310 1000 TABLET in 1 BOTTLE (64980-723-10) 1000 tablet 2026-07-20 No No Current