amlodipine besylate

Generic: amlodipine besylate

Labeler: aci healthcare usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler aci healthcare usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1

Manufacturer
ACI Healthcare USA, Inc.

Identifiers & Regulatory

Product NDC 71093-148
Product ID 71093-148_5a93579c-5d45-4662-b39c-8d93b04f52dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077516
Listing Expiration 2026-12-31
Marketing Start 2011-04-15

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 71093148
Hyphenated Format 71093-148

Supplemental Identifiers

RxCUI
197361 308135 308136
UNII
864V2Q084H

Packaging Origin

Original Packager
true

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 ANDA077516 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (71093-148-03)
  • 500 TABLET in 1 BOTTLE (71093-148-05)
  • 1000 TABLET in 1 BOTTLE (71093-148-06)
source: ndc

Packages (3)

71093-148-03 90 TABLET in 1 BOTTLE (71093-148-03) 71093-148-05 500 TABLET in 1 BOTTLE (71093-148-05) 71093-148-06 1000 TABLET in 1 BOTTLE (71093-148-06)

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": "5a93579c-5d45-4662-b39c-8d93b04f52dc", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["b431dceb-a3d3-4d53-9d0f-c6a452c584d7"], "manufacturer_name": ["ACI Healthcare USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (71093-148-03)", "package_ndc": "71093-148-03", "marketing_start_date": "20181112"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (71093-148-05)", "package_ndc": "71093-148-05", "marketing_start_date": "20181112"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (71093-148-06)", "package_ndc": "71093-148-06", "marketing_start_date": "20181112"}], "brand_name": "AMLODIPINE BESYLATE", "product_id": "71093-148_5a93579c-5d45-4662-b39c-8d93b04f52dc", "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": "71093-148", "generic_name": "AMLODIPINE BESYLATE", "labeler_name": "ACI Healthcare USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMLODIPINE BESYLATE", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA077516", "marketing_category": "ANDA", "marketing_start_date": "20110415", "listing_expiration_date": "20261231"}