amlodipine besylate

Generic: amlodipine besylate

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-496
Product ID 60687-496_2251e2e4-cefb-7d15-e063-6394a90a8cb0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078925
Listing Expiration 2026-12-31
Marketing Start 2019-08-22

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 60687496
Hyphenated Format 60687-496

Supplemental Identifiers

RxCUI
197361 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 ANDA078925 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-496-01) / 1 TABLET in 1 BLISTER PACK (60687-496-11)
source: ndc

Packages (1)

60687-496-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-496-01) / 1 TABLET in 1 BLISTER PACK (60687-496-11)

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": "2251e2e4-cefb-7d15-e063-6394a90a8cb0", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361", "308135"], "spl_set_id": ["44f7e13f-b90f-477b-86cf-21667d90f9a9"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-496-01)  / 1 TABLET in 1 BLISTER PACK (60687-496-11)", "package_ndc": "60687-496-01", "marketing_start_date": "20190822"}], "brand_name": "Amlodipine Besylate", "product_id": "60687-496_2251e2e4-cefb-7d15-e063-6394a90a8cb0", "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": "60687-496", "generic_name": "Amlodipine besylate", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA078925", "marketing_category": "ANDA", "marketing_start_date": "20190822", "listing_expiration_date": "20261231"}