amlodipine besylate

Generic: amlodipine besylate

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler quality care products, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-035
Product ID 83008-035_32b4fbba-6ca8-465d-88eb-19fe414a5c85
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203245
Marketing Start 2023-07-20
Marketing End 2027-02-28

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 83008035
Hyphenated Format 83008-035

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 BOTTLE, PLASTIC (83008-035-30)
source: ndc

Packages (1)

83008-035-30 30 TABLET in 1 BOTTLE, PLASTIC (83008-035-30)

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": "32b4fbba-6ca8-465d-88eb-19fe414a5c85", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361"], "spl_set_id": ["a75e4797-6b7f-4366-9105-79d6877adac5"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (83008-035-30)", "package_ndc": "83008-035-30", "marketing_end_date": "20270228", "marketing_start_date": "20230720"}], "brand_name": "Amlodipine Besylate", "product_id": "83008-035_32b4fbba-6ca8-465d-88eb-19fe414a5c85", "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": "83008-035", "generic_name": "Amlodipine Besylate", "labeler_name": "Quality Care Products, LLC", "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_end_date": "20270228", "marketing_start_date": "20230720"}