amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: preferred 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 preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8836
Product ID 68788-8836_a0822381-ba9a-4f80-bc4f-608301d07fd8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091568
Listing Expiration 2026-12-31
Marketing Start 2025-02-27

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 687888836
Hyphenated Format 68788-8836

Supplemental Identifiers

RxCUI
562508
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 ANDA091568 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 875 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (68788-8836-2)
source: ndc

Packages (1)

68788-8836-2 20 TABLET, FILM COATED in 1 BOTTLE (68788-8836-2)

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": "a0822381-ba9a-4f80-bc4f-608301d07fd8", "openfda": {"unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["562508"], "spl_set_id": ["a0822381-ba9a-4f80-bc4f-608301d07fd8"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68788-8836-2)", "package_ndc": "68788-8836-2", "marketing_start_date": "20250227"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "68788-8836_a0822381-ba9a-4f80-bc4f-608301d07fd8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "68788-8836", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "Preferred 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": "ANDA091568", "marketing_category": "ANDA", "marketing_start_date": "20250227", "listing_expiration_date": "20261231"}