Home NDC 71335-1887 AMLODIPINE BESYLATE
Product NDC 71335-1887
11-digit product format 713351887
Labeler code 71335
Product ID 71335-1887_42be4afb-caa4-4ad4-b489-bd42b182ea9c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMLODIPINE BESYLATE
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA077516
Marketing category ANDA
Marketing start 2011-04-15
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 2026-12-31
Current FDA listing Yes 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 A077516-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-11 A077516-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-11 A077516-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-11
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 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
Additional Listing Data#
Finished product Yes
Brand name base AMLODIPINE BESYLATE
Listing expiration 2026-12-31 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1887 AMLODIPINE BESYLATE TABLET [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 9 package rows 20230328_cb3da88f-cee0-4c22-9760-a50edc8fc140.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 Marketing end Sample Exclude flag Status 71335-1887-1 71335188701 30 TABLET in 1 BOTTLE (71335-1887-1) 30 tablet 2021-08-09 0000-00-00 No No Current 71335-1887-2 71335188702 90 TABLET in 1 BOTTLE (71335-1887-2) 90 tablet 2021-07-27 0000-00-00 No No Current 71335-1887-3 71335188703 60 TABLET in 1 BOTTLE (71335-1887-3) 60 tablet 2021-08-24 0000-00-00 No No Current 71335-1887-4 71335188704 120 TABLET in 1 BOTTLE (71335-1887-4) 120 tablet 2022-02-15 0000-00-00 No No Current 71335-1887-5 71335188705 100 TABLET in 1 BOTTLE (71335-1887-5) 100 tablet 2021-08-03 0000-00-00 No No Current 71335-1887-6 71335188706 800 TABLET in 1 BOTTLE (71335-1887-6) 800 tablet 2022-02-15 0000-00-00 No No Current 71335-1887-7 71335188707 1000 TABLET in 1 BOTTLE (71335-1887-7) 1000 tablet 2022-02-15 0000-00-00 No No Current 71335-1887-8 71335188708 180 TABLET in 1 BOTTLE (71335-1887-8) 180 tablet 2022-02-15 0000-00-00 No No Current 71335-1887-9 71335188709 10 TABLET in 1 BOTTLE (71335-1887-9) 10 tablet 2022-02-15 0000-00-00 No No Current