Amlodipine Besylate

Generic: Amlodipine Besylate

Labeler: Preferred Pharmaceuticals Inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name Amlodipine Besylate
Generic Name Amlodipine Besylate
Labeler Preferred Pharmaceuticals Inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

AMLODIPINE BESYLATE 5 mg/1

Identifiers & Regulatory

Product NDC 68788-8313
Product ID 68788-8313_af568987-c29a-4a5c-94c8-6010567a101f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203245
Listing Expiration 2026-12-31
Marketing Start 2022-12-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888313
Hyphenated Format 68788-8313

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
  • 100 TABLET in 1 BOTTLE, PLASTIC (68788-8313-1)
  • 30 TABLET in 1 BOTTLE, PLASTIC (68788-8313-3)
  • 60 TABLET in 1 BOTTLE, PLASTIC (68788-8313-6)
  • 90 TABLET in 1 BOTTLE, PLASTIC (68788-8313-9)
source: ndc

Packages (4)

68788-8313-1 100 TABLET in 1 BOTTLE, PLASTIC (68788-8313-1) 68788-8313-3 30 TABLET in 1 BOTTLE, PLASTIC (68788-8313-3) 68788-8313-6 60 TABLET in 1 BOTTLE, PLASTIC (68788-8313-6) 68788-8313-9 90 TABLET in 1 BOTTLE, PLASTIC (68788-8313-9)

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": "af568987-c29a-4a5c-94c8-6010567a101f", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361"], "spl_set_id": ["6fd0c316-454f-4784-a6d2-d7cb7e753f41"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (68788-8313-1)", "package_ndc": "68788-8313-1", "marketing_start_date": "20221221"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (68788-8313-3)", "package_ndc": "68788-8313-3", "marketing_start_date": "20221221"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (68788-8313-6)", "package_ndc": "68788-8313-6", "marketing_start_date": "20221221"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (68788-8313-9)", "package_ndc": "68788-8313-9", "marketing_start_date": "20221221"}], "brand_name": "Amlodipine Besylate", "product_id": "68788-8313_af568987-c29a-4a5c-94c8-6010567a101f", "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": "68788-8313", "generic_name": "Amlodipine Besylate", "labeler_name": "Preferred Pharmaceuticals 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": "20221221", "listing_expiration_date": "20261231"}