amlodipine besylate

Generic: amlodipine besylate

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-516
Product ID 72789-516_4c3903d1-1829-2695-e063-6294a90ab6a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076719
Listing Expiration 2027-12-31
Marketing Start 2007-05-23

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 72789516
Hyphenated Format 72789-516

Supplemental Identifiers

RxCUI
197361 308135 308136
UPC
0372789515953 0372789514956 0372789516950
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 ANDA076719 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (72789-516-30)
  • 90 TABLET in 1 BOTTLE, PLASTIC (72789-516-90)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (72789-516-95)
source: ndc

Packages (3)

72789-516-30 30 TABLET in 1 BOTTLE, PLASTIC (72789-516-30) 72789-516-90 90 TABLET in 1 BOTTLE, PLASTIC (72789-516-90) 72789-516-95 1000 TABLET in 1 BOTTLE, PLASTIC (72789-516-95)

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": "4c3903d1-1829-2695-e063-6294a90ab6a6", "openfda": {"upc": ["0372789515953", "0372789514956", "0372789516950"], "unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["5a0b3dd4-91f5-4173-a992-e91b1cac6a18"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72789-516-30)", "package_ndc": "72789-516-30", "marketing_start_date": "20250930"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (72789-516-90)", "package_ndc": "72789-516-90", "marketing_start_date": "20251027"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (72789-516-95)", "package_ndc": "72789-516-95", "marketing_start_date": "20250626"}], "brand_name": "Amlodipine Besylate", "product_id": "72789-516_4c3903d1-1829-2695-e063-6294a90ab6a6", "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": "72789-516", "generic_name": "Amlodipine Besylate", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA076719", "marketing_category": "ANDA", "marketing_start_date": "20070523", "listing_expiration_date": "20271231"}