amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: asclemed usa, 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 asclemed usa, inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

amoxicillin 400 mg/5mL, clavulanate potassium 57 mg/5mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-864
Product ID 76420-864_25322eee-f92a-5838-e063-6394a90aa376
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201090
Listing Expiration 2026-12-31
Marketing Start 2011-12-20

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 76420864
Hyphenated Format 76420-864

Supplemental Identifiers

RxCUI
617423 617430
UNII
Q42OMW3AT8 804826J2HU

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 ANDA201090 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/5mL
  • 57 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (76420-864-01)
  • 50 mL in 1 BOTTLE (76420-864-50)
  • 75 mL in 1 BOTTLE (76420-864-75)
source: ndc

Packages (3)

76420-864-01 100 mL in 1 BOTTLE (76420-864-01) 76420-864-50 50 mL in 1 BOTTLE (76420-864-50) 76420-864-75 75 mL in 1 BOTTLE (76420-864-75)

Ingredients (2)

amoxicillin (400 mg/5mL) clavulanate potassium (57 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": "25322eee-f92a-5838-e063-6394a90aa376", "openfda": {"unii": ["Q42OMW3AT8", "804826J2HU"], "rxcui": ["617423", "617430"], "spl_set_id": ["fc5dc69a-3c23-49fc-b80f-1412aebc9b76"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (76420-864-01)", "package_ndc": "76420-864-01", "marketing_start_date": "20241024"}, {"sample": false, "description": "50 mL in 1 BOTTLE (76420-864-50)", "package_ndc": "76420-864-50", "marketing_start_date": "20241024"}, {"sample": false, "description": "75 mL in 1 BOTTLE (76420-864-75)", "package_ndc": "76420-864-75", "marketing_start_date": "20241024"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "76420-864_25322eee-f92a-5838-e063-6394a90aa376", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "76420-864", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin and Clavulanate Potassium", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "400 mg/5mL"}, {"name": "CLAVULANATE POTASSIUM", "strength": "57 mg/5mL"}], "application_number": "ANDA201090", "marketing_category": "ANDA", "marketing_start_date": "20111220", "listing_expiration_date": "20261231"}