amoxicillin and clavulanate potassium (0143-9981)

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium

Generic Name amoxicillin and clavulanate potassium

Labeler hikma pharmaceuticals usa inc.

Dosage Form POWDER, FOR SUSPENSION

Routes

ORAL

Active Ingredients

amoxicillin 200 mg/5mL, clavulanic acid 28.5 mg/5mL

Manufacturer

Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9981

Product ID 0143-9981_d26c7880-d893-458e-8cc9-327a8ad2d7df

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA065191

Listing Expiration 2026-12-31

Marketing Start 2007-12-01

Pharmacologic Class

Established (EPC)

beta lactamase inhibitor [epc]

Mechanism of Action

beta lactamase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439981

Hyphenated Format 0143-9981

Supplemental Identifiers

RxCUI

617423 617430

UPC

0301439981015 0301439982012

UNII

804826J2HU 23521W1S24

NUI

N0000175930 N0000000202

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 ANDA065191 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/5mL
28.5 mg/5mL

source: ndc

Packaging

100 mL in 1 BOTTLE (0143-9981-01)
50 mL in 1 BOTTLE (0143-9981-50)
75 mL in 1 BOTTLE (0143-9981-75)

source: ndc

Packages (3)

0143-9981-01 100 mL in 1 BOTTLE (0143-9981-01) 0143-9981-50 50 mL in 1 BOTTLE (0143-9981-50) 0143-9981-75 75 mL in 1 BOTTLE (0143-9981-75)

Ingredients (2)

amoxicillin (200 mg/5mL) clavulanic acid (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": "d26c7880-d893-458e-8cc9-327a8ad2d7df", "openfda": {"nui": ["N0000175930", "N0000000202"], "upc": ["0301439981015", "0301439982012"], "unii": ["804826J2HU", "23521W1S24"], "rxcui": ["617423", "617430"], "spl_set_id": ["240bcdcb-31d9-40a0-87e1-bd16264a2e20"], "pharm_class_epc": ["beta Lactamase Inhibitor [EPC]"], "pharm_class_moa": ["beta Lactamase Inhibitors [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (0143-9981-01)", "package_ndc": "0143-9981-01", "marketing_start_date": "20071201"}, {"sample": false, "description": "50 mL in 1 BOTTLE (0143-9981-50)", "package_ndc": "0143-9981-50", "marketing_start_date": "20071201"}, {"sample": false, "description": "75 mL in 1 BOTTLE (0143-9981-75)", "package_ndc": "0143-9981-75", "marketing_start_date": "20071201"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "0143-9981_d26c7880-d893-458e-8cc9-327a8ad2d7df", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "0143-9981", "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": "200 mg/5mL"}, {"name": "CLAVULANIC ACID", "strength": "28.5 mg/5mL"}], "application_number": "ANDA065191", "marketing_category": "ANDA", "marketing_start_date": "20071201", "listing_expiration_date": "20261231"}