Amoxicillin and Clavulanate Potassium

Generic: Amoxicillin and Clavulanate Potassium

Labeler: Preferred Pharmaceuticals Inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name Amoxicillin and Clavulanate Potassium
Generic Name Amoxicillin and Clavulanate Potassium
Labeler Preferred Pharmaceuticals Inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

AMOXICILLIN 200 mg/5mL, CLAVULANATE POTASSIUM 28.5 mg/5mL

Identifiers & Regulatory

Product NDC 68788-8000
Product ID 68788-8000_3ffb94bf-62b9-4eb0-8821-4f29ca02a094
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065066
Listing Expiration 2026-12-31
Marketing Start 2021-08-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888000
Hyphenated Format 68788-8000

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 ANDA065066 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
  • 28.5 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (68788-8000-1)
source: ndc

Packages (1)

68788-8000-1 100 mL in 1 BOTTLE (68788-8000-1)

Ingredients (2)

AMOXICILLIN (200 mg/5mL) CLAVULANATE POTASSIUM (28.5 mg/5mL)

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": "3ffb94bf-62b9-4eb0-8821-4f29ca02a094", "openfda": {"unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["617423"], "spl_set_id": ["51ee76f6-b699-4e50-b7a9-0477580d1f14"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (68788-8000-1)", "package_ndc": "68788-8000-1", "marketing_start_date": "20210810"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "68788-8000_3ffb94bf-62b9-4eb0-8821-4f29ca02a094", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "68788-8000", "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": "200 mg/5mL"}, {"name": "CLAVULANATE POTASSIUM", "strength": "28.5 mg/5mL"}], "application_number": "ANDA065066", "marketing_category": "ANDA", "marketing_start_date": "20210810", "listing_expiration_date": "20261231"}