amlodipine besylate

Generic: amlodipine besylate

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3592
Product ID 70518-3592_3c2a847c-0462-2806-e063-6394a90a18a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203245
Listing Expiration 2026-12-31
Marketing Start 2022-12-07

Pharmacologic Class

Classes
calcium channel antagonists [moa] calcium channel blocker [epc] cytochrome p450 3a inhibitors [moa] dihydropyridine calcium channel blocker [epc] dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183592
Hyphenated Format 70518-3592

Supplemental Identifiers

RxCUI
197361
UNII
864V2Q084H

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name amlodipine besylate (source: ndc)
Generic Name amlodipine besylate (source: ndc)
Application Number ANDA203245 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-3592-0)
  • 90 TABLET in 1 BOTTLE, PLASTIC (70518-3592-1)
  • 30 TABLET in 1 BOTTLE, PLASTIC (70518-3592-2)
  • 90 TABLET in 1 BOTTLE, PLASTIC (70518-3592-3)
source: ndc

Packages (4)

70518-3592-0 30 TABLET in 1 BLISTER PACK (70518-3592-0) 70518-3592-1 90 TABLET in 1 BOTTLE, PLASTIC (70518-3592-1) 70518-3592-2 30 TABLET in 1 BOTTLE, PLASTIC (70518-3592-2) 70518-3592-3 90 TABLET in 1 BOTTLE, PLASTIC (70518-3592-3)

Ingredients (1)

amlodipine besylate (5 mg/1)

Linked Drug Pages (1)

Amlodipine Besylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3c2a847c-0462-2806-e063-6394a90a18a0", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361"], "spl_set_id": ["988e5acb-356e-4116-b6db-ab8468ed7234"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-3592-0)", "package_ndc": "70518-3592-0", "marketing_start_date": "20221207"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-3592-1)", "package_ndc": "70518-3592-1", "marketing_start_date": "20230126"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (70518-3592-2)", "package_ndc": "70518-3592-2", "marketing_start_date": "20240820"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-3592-3)", "package_ndc": "70518-3592-3", "marketing_start_date": "20250811"}], "brand_name": "Amlodipine Besylate", "product_id": "70518-3592_3c2a847c-0462-2806-e063-6394a90a18a0", "dosage_form": "TABLET", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "70518-3592", "generic_name": "Amlodipine Besylate", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}], "application_number": "ANDA203245", "marketing_category": "ANDA", "marketing_start_date": "20221207", "listing_expiration_date": "20261231"}