amlodipine besylate

Generic: amlodipine besylate

Labeler: boswell pharmacy services llc d/b/a bps wholesale
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler boswell pharmacy services llc d/b/a bps wholesale
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1

Manufacturer
Boswell Pharmacy Services LLC d/b/a BPS Wholesale

Identifiers & Regulatory

Product NDC 83209-399
Product ID 83209-399_41af330c-81e2-db2d-e063-6294a90a005c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203245
Listing Expiration 2026-12-31
Marketing Start 2025-10-21

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 83209399
Hyphenated Format 83209-399

Supplemental Identifiers

RxCUI
308135
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
  • 10 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BLISTER PACK (83209-399-10)
  • 15 TABLET in 1 BLISTER PACK (83209-399-15)
  • 20 TABLET in 1 BLISTER PACK (83209-399-20)
  • 30 TABLET in 1 BLISTER PACK (83209-399-30)
  • 60 TABLET in 1 BLISTER PACK (83209-399-60)
source: ndc

Packages (5)

83209-399-10 10 TABLET in 1 BLISTER PACK (83209-399-10) 83209-399-15 15 TABLET in 1 BLISTER PACK (83209-399-15) 83209-399-20 20 TABLET in 1 BLISTER PACK (83209-399-20) 83209-399-30 30 TABLET in 1 BLISTER PACK (83209-399-30) 83209-399-60 60 TABLET in 1 BLISTER PACK (83209-399-60)

Ingredients (1)

amlodipine besylate (10 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": "41af330c-81e2-db2d-e063-6294a90a005c", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["308135"], "spl_set_id": ["41af64c4-b788-d827-e063-6394a90a9157"], "manufacturer_name": ["Boswell Pharmacy Services LLC d/b/a BPS Wholesale"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BLISTER PACK (83209-399-10)", "package_ndc": "83209-399-10", "marketing_start_date": "20251021"}, {"sample": false, "description": "15 TABLET in 1 BLISTER PACK (83209-399-15)", "package_ndc": "83209-399-15", "marketing_start_date": "20251021"}, {"sample": false, "description": "20 TABLET in 1 BLISTER PACK (83209-399-20)", "package_ndc": "83209-399-20", "marketing_start_date": "20251021"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (83209-399-30)", "package_ndc": "83209-399-30", "marketing_start_date": "20251021"}, {"sample": false, "description": "60 TABLET in 1 BLISTER PACK (83209-399-60)", "package_ndc": "83209-399-60", "marketing_start_date": "20251021"}], "brand_name": "Amlodipine Besylate", "product_id": "83209-399_41af330c-81e2-db2d-e063-6294a90a005c", "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": "83209-399", "generic_name": "Amlodipine Besylate", "labeler_name": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA203245", "marketing_category": "ANDA", "marketing_start_date": "20251021", "listing_expiration_date": "20261231"}