amlodipine besylate

Generic: amlodipine besylate

Labeler: redpharm drug
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler redpharm drug
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1

Manufacturer
Redpharm Drug

Identifiers & Regulatory

Product NDC 67296-1876
Product ID 67296-1876_2c62f690-8df4-d28e-e063-6394a90a45a2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203245
Listing Expiration 2026-12-31
Marketing Start 2019-05-22

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 672961876
Hyphenated Format 67296-1876

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 (67296-1876-9)
source: ndc

Packages (1)

67296-1876-9 30 TABLET in 1 BOTTLE (67296-1876-9)

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": "2c62f690-8df4-d28e-e063-6394a90a45a2", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361"], "spl_set_id": ["fc61eee9-ee15-9078-e053-6394a90a22f4"], "manufacturer_name": ["Redpharm Drug"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (67296-1876-9)", "package_ndc": "67296-1876-9", "marketing_start_date": "20200622"}], "brand_name": "Amlodipine Besylate", "product_id": "67296-1876_2c62f690-8df4-d28e-e063-6394a90a45a2", "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": "67296-1876", "generic_name": "Amlodipine Besylate", "labeler_name": "Redpharm Drug", "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": "20190522", "listing_expiration_date": "20261231"}