amlodipine besylate 10 mg

Generic: amlodipine besylate

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

Drug Facts

Product Profile

Brand Name amlodipine besylate 10 mg
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 72789-262
Product ID 72789-262_41d6707a-c54e-5987-e063-6294a90ab185
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078414
Listing Expiration 2026-12-31
Marketing Start 2021-10-01

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 72789262
Hyphenated Format 72789-262

Supplemental Identifiers

RxCUI
197361 308135 308136
UPC
0372789262956 0372789261959 0372789260952
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 10 mg (source: ndc)
Generic Name amlodipine besylate (source: ndc)
Application Number ANDA078414 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (72789-262-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (72789-262-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (72789-262-90)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (72789-262-95)
source: ndc

Packages (4)

72789-262-30 30 TABLET in 1 BOTTLE, PLASTIC (72789-262-30) 72789-262-60 60 TABLET in 1 BOTTLE, PLASTIC (72789-262-60) 72789-262-90 90 TABLET in 1 BOTTLE, PLASTIC (72789-262-90) 72789-262-95 1000 TABLET in 1 BOTTLE, PLASTIC (72789-262-95)

Ingredients (1)

amlodipine besylate (10 mg/1)

Linked Drug Pages (1)

AMLODIPINE BESYLATE 2.5 mg, AMLODIPINE BESYLATE 5 mg, AMLODIPINE BESYLATE 10 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41d6707a-c54e-5987-e063-6294a90ab185", "openfda": {"upc": ["0372789262956", "0372789261959", "0372789260952"], "unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["1080fcea-a5da-499d-a855-690c13559071"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72789-262-30)", "package_ndc": "72789-262-30", "marketing_start_date": "20230421"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (72789-262-60)", "package_ndc": "72789-262-60", "marketing_start_date": "20230421"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (72789-262-90)", "package_ndc": "72789-262-90", "marketing_start_date": "20220715"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (72789-262-95)", "package_ndc": "72789-262-95", "marketing_start_date": "20220715"}], "brand_name": "AMLODIPINE BESYLATE 10 mg", "product_id": "72789-262_41d6707a-c54e-5987-e063-6294a90ab185", "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": "72789-262", "generic_name": "AMLODIPINE BESYLATE", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMLODIPINE BESYLATE", "brand_name_suffix": "10 mg", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA078414", "marketing_category": "ANDA", "marketing_start_date": "20211001", "listing_expiration_date": "20261231"}