amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: hikma pharmaceuticals 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 hikma pharmaceuticals usa inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

amoxicillin 600 mg/5mL, clavulanate potassium 42.9 mg/5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9853
Product ID 0143-9853_45f95702-3be8-47a5-8de8-3b17457aa04a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065373
Listing Expiration 2026-12-31
Marketing Start 2009-08-03

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 01439853
Hyphenated Format 0143-9853

Supplemental Identifiers

RxCUI
617993
UPC
0301439853244 0301439853169 0301439853756
UNII
804826J2HU Q42OMW3AT8

Packaging Origin

Original Packager
true

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 ANDA065373 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/5mL
  • 42.9 mg/5mL
source: ndc
Packaging
  • 125 mL in 1 BOTTLE (0143-9853-16)
  • 200 mL in 1 BOTTLE (0143-9853-24)
  • 75 mL in 1 BOTTLE (0143-9853-75)
source: ndc

Packages (3)

0143-9853-16 125 mL in 1 BOTTLE (0143-9853-16) 0143-9853-24 200 mL in 1 BOTTLE (0143-9853-24) 0143-9853-75 75 mL in 1 BOTTLE (0143-9853-75)

Ingredients (2)

amoxicillin (600 mg/5mL) clavulanate potassium (42.9 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": "45f95702-3be8-47a5-8de8-3b17457aa04a", "openfda": {"upc": ["0301439853244", "0301439853169", "0301439853756"], "unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["617993"], "spl_set_id": ["6339bcdb-060f-4558-9f42-6bf7f935e138"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "125 mL in 1 BOTTLE (0143-9853-16)", "package_ndc": "0143-9853-16", "marketing_start_date": "20090803"}, {"sample": false, "description": "200 mL in 1 BOTTLE (0143-9853-24)", "package_ndc": "0143-9853-24", "marketing_start_date": "20090803"}, {"sample": false, "description": "75 mL in 1 BOTTLE (0143-9853-75)", "package_ndc": "0143-9853-75", "marketing_start_date": "20090803"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "0143-9853_45f95702-3be8-47a5-8de8-3b17457aa04a", "dosage_form": "SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "0143-9853", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin and Clavulanate Potassium", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "600 mg/5mL"}, {"name": "CLAVULANATE POTASSIUM", "strength": "42.9 mg/5mL"}], "application_number": "ANDA065373", "marketing_category": "ANDA", "marketing_start_date": "20090803", "listing_expiration_date": "20261231"}