Home NDC 71610-988 Amlodipine Besylate
Product NDC 71610-988
11-digit product format 716100988
Labeler code 71610
Product ID 71610-988_4a2baf2b-9abf-e333-e063-6294a90a110c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine Besylate
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA076719
Marketing category ANDA
Marketing start 2007-05-23
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A076719-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-05-23 A076719-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-05-23 A076719-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-05-23
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 · 123 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 2026-02-19 14:30 UTC 2026-02 A076719-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076719-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076719-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076719-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076719-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076719-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076719-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076719-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076719-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076719-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076719-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076719-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076719-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076719-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076719-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076719-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076719-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076719-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076719-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076719-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076719-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076719-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076719-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076719-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076719-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076719-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076719-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076719-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076719-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076719-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076719-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-05-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076719-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-05-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076719-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076719-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-05-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076719-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-05-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076719-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076719-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-05-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076719-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-05-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076719-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076719-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-05-23 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 10 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308135 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 71610-988-30 Amlodipine Besylate 30 in 1 BOTTLE TABLET 30 1 71610-988-45 Amlodipine Besylate 45 in 1 BOTTLE TABLET 45 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 1 of 1 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Amlodipine Besylate AMLODIPINE BESYLATE PD-Rx Pharmaceuticals, Inc. 5a0b3dd4-91f5-4173-a992-e91b1cac6a18 2026-05-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076719 application number: ANDA076719 Amlodipine Besylate AMLODIPINE BESYLATE Aphena Pharma Solutions - Tennessee, LLC 4a2bba2d-9b7a-f43a-e063-6294a90af80e 2026-02-06 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076719 application number: ANDA076719 ndc (product): 71610-988 Amlodipine Besylate AMLODIPINE BESYLATE Aphena Pharma Solutions - Tennessee, LLC 41496b0d-f1ca-4e9d-e063-6394a90aec1d 2026-01-29 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076719 application number: ANDA076719 Amlodipine Besylate AMLODIPINE BESYLATE Aphena Pharma Solutions - Tennessee, LLC 3ab4ad3d-7795-058a-e063-6294a90abc86 2026-01-23 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076719 application number: ANDA076719 Amlodipine Besylate AMLODIPINE BESYLATE GSMS, Incorporated 9c0f83f4-06ad-4bb1-a8e3-dcac43b840cf 2025-03-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076719 application number: ANDA076719
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71610-988-30 71610098830 30 TABLET in 1 BOTTLE (71610-988-30) 30 tablet 2026-02-06 No No Current 71610-988-45 71610098845 45 TABLET in 1 BOTTLE (71610-988-45) 45 tablet 2026-02-06 No No Current