amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

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

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium
Generic Name amoxicillin and clavulanate potassium
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amoxicillin 875 mg/1, clavulanate potassium 125 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-147
Product ID 72789-147_4af780a9-9cb0-97f0-e063-6294a90a61c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203824
Listing Expiration 2027-12-31
Marketing Start 2016-08-23

Pharmacologic Class

Classes
penicillin-class antibacterial [epc] penicillins [cs] beta lactamase inhibitor [epc] beta lactamase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789147
Hyphenated Format 72789-147

Supplemental Identifiers

RxCUI
562508
UPC
0372789147208
UNII
804826J2HU Q42OMW3AT8

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 amoxicillin and clavulanate potassium (source: ndc)
Generic Name amoxicillin and clavulanate potassium (source: ndc)
Application Number ANDA203824 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 875 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 3 TABLET in 1 BOTTLE, PLASTIC (72789-147-03)
  • 4 TABLET in 1 BOTTLE, PLASTIC (72789-147-04)
  • 10 TABLET in 1 BOTTLE, PLASTIC (72789-147-10)
  • 14 TABLET in 1 BOTTLE, PLASTIC (72789-147-14)
  • 20 TABLET in 1 BOTTLE, PLASTIC (72789-147-20)
  • 28 TABLET in 1 BOTTLE, PLASTIC (72789-147-28)
  • 30 TABLET in 1 BOTTLE, PLASTIC (72789-147-30)
source: ndc

Packages (7)

72789-147-03 3 TABLET in 1 BOTTLE, PLASTIC (72789-147-03) 72789-147-04 4 TABLET in 1 BOTTLE, PLASTIC (72789-147-04) 72789-147-10 10 TABLET in 1 BOTTLE, PLASTIC (72789-147-10) 72789-147-14 14 TABLET in 1 BOTTLE, PLASTIC (72789-147-14) 72789-147-20 20 TABLET in 1 BOTTLE, PLASTIC (72789-147-20) 72789-147-28 28 TABLET in 1 BOTTLE, PLASTIC (72789-147-28) 72789-147-30 30 TABLET in 1 BOTTLE, PLASTIC (72789-147-30)

Ingredients (2)

amoxicillin (875 mg/1) clavulanate potassium (125 mg/1)

Linked Drug Pages (1)

Amoxicillin and Clavulanate Potassium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4af780a9-9cb0-97f0-e063-6294a90a61c1", "openfda": {"upc": ["0372789147208"], "unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["562508"], "spl_set_id": ["f229e8b4-7045-4c0d-9214-890c0bda3c2a"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET in 1 BOTTLE, PLASTIC (72789-147-03)", "package_ndc": "72789-147-03", "marketing_start_date": "20200515"}, {"sample": false, "description": "4 TABLET in 1 BOTTLE, PLASTIC (72789-147-04)", "package_ndc": "72789-147-04", "marketing_start_date": "20201111"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (72789-147-10)", "package_ndc": "72789-147-10", "marketing_start_date": "20201230"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE, PLASTIC (72789-147-14)", "package_ndc": "72789-147-14", "marketing_start_date": "20201117"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (72789-147-20)", "package_ndc": "72789-147-20", "marketing_start_date": "20201111"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE, PLASTIC (72789-147-28)", "package_ndc": "72789-147-28", "marketing_start_date": "20210429"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72789-147-30)", "package_ndc": "72789-147-30", "marketing_start_date": "20201111"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "72789-147_4af780a9-9cb0-97f0-e063-6294a90a61c1", "dosage_form": "TABLET", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "72789-147", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin and Clavulanate Potassium", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "875 mg/1"}, {"name": "CLAVULANATE POTASSIUM", "strength": "125 mg/1"}], "application_number": "ANDA203824", "marketing_category": "ANDA", "marketing_start_date": "20160823", "listing_expiration_date": "20271231"}