amlodipine besylate

Generic: amlodipine besylate

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-199
Product ID 67877-199_9fb4b641-2b16-4bcb-89de-d8d5893916ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078925
Listing Expiration 2026-12-31
Marketing Start 2010-10-20

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 67877199
Hyphenated Format 67877-199

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 ANDA078925 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (67877-199-05)
  • 1000 TABLET in 1 BOTTLE (67877-199-10)
  • 10 BLISTER PACK in 1 CARTON (67877-199-38) / 10 TABLET in 1 BLISTER PACK
  • 90 TABLET in 1 BOTTLE (67877-199-90)
source: ndc

Packages (4)

67877-199-05 500 TABLET in 1 BOTTLE (67877-199-05) 67877-199-10 1000 TABLET in 1 BOTTLE (67877-199-10) 67877-199-38 10 BLISTER PACK in 1 CARTON (67877-199-38) / 10 TABLET in 1 BLISTER PACK 67877-199-90 90 TABLET in 1 BOTTLE (67877-199-90)

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": "9fb4b641-2b16-4bcb-89de-d8d5893916ec", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["3f4703c0-0b9e-41a0-8b70-da26683d9ed2"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (67877-199-05)", "package_ndc": "67877-199-05", "marketing_start_date": "20101020"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (67877-199-10)", "package_ndc": "67877-199-10", "marketing_start_date": "20101020"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-199-38)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "67877-199-38", "marketing_start_date": "20101020"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (67877-199-90)", "package_ndc": "67877-199-90", "marketing_start_date": "20101020"}], "brand_name": "Amlodipine Besylate", "product_id": "67877-199_9fb4b641-2b16-4bcb-89de-d8d5893916ec", "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": "67877-199", "generic_name": "Amlodipine besylate", "labeler_name": "Ascend Laboratories, LLC", "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": "20101020", "listing_expiration_date": "20261231"}