Home NDC 71335-1887-1 AMLODIPINE BESYLATE
Product NDC 71335-1887
Requested package NDC 71335-1887-1
11-digit product format 713351887
Labeler code 71335
Product ID 71335-1887_cb3da88f-cee0-4c22-9760-a50edc8fc140
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
Marketing end 0000-00-00
Substance AMLODIPINE BESYLATE
Active strength 10 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 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 · 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 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-11 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Legacy NDC, 9 package rows 20230328_cb3da88f-cee0-4c22-9760-a50edc8fc140.zip
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