Home NDC 83008-035 Amlodipine Besylate
Product NDC 83008-035
11-digit product format 830080035
Labeler code 83008
Product ID 83008-035_32b4fbba-6ca8-465d-88eb-19fe414a5c85
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine Besylate
Dosage form TABLET
Route ORAL
Labeler Quality Care Products, LLC
Application ANDA203245
Marketing category ANDA
Marketing start 2023-07-20
Marketing end 2027-02-28
Substance AMLODIPINE BESYLATE
Active strength 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
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 Active Ingredients# Ingredient, Strength table Ingredient Strength AMLODIPINE BESYLATE 5 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 197361 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 83008-035-30 Amlodipine Besylate 30 in 1 BOTTLE, PLASTIC TABLET 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83008-035 AMLODIPINE BESYLATE TABLET [QUALITY CARE PRODUCTS, LLC] 4 Current NDC, 1 package rows 20241222_a75e4797-6b7f-4366-9105-79d6877adac5.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 2 of 2 · 21 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 83008-035-30 83008003530 30 TABLET in 1 BOTTLE, PLASTIC (83008-035-30) 30 tablet 2023-07-20 2027-02-28 No No Historical