amoxicillin and clavulanate potassium (50090-0928)

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium

Generic Name amoxicillin and clavulanate potassium

Labeler a-s medication solutions

Dosage Form POWDER, FOR SUSPENSION

Routes

ORAL

Active Ingredients

amoxicillin 400 mg/5mL, clavulanic acid 57 mg/5mL

Manufacturer

A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-0928

Product ID 50090-0928_26c0009a-da21-48b0-a02a-2161e335a2c7

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA065191

Listing Expiration 2027-12-31

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 500900928

Hyphenated Format 50090-0928

Supplemental Identifiers

RxCUI

617430

UNII

804826J2HU 23521W1S24

NUI

N0000175930 N0000000202

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

400 mg/5mL
57 mg/5mL

source: ndc

Packaging

50 mL in 1 BOTTLE (50090-0928-0)

source: ndc

Packages (1)

50090-0928-0 50 mL in 1 BOTTLE (50090-0928-0)

Ingredients (2)

amoxicillin (400 mg/5mL) clavulanic acid (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": "26c0009a-da21-48b0-a02a-2161e335a2c7", "openfda": {"nui": ["N0000175930", "N0000000202"], "unii": ["804826J2HU", "23521W1S24"], "rxcui": ["617430"], "spl_set_id": ["483f6fca-e04e-4086-aa44-a361322b811d"], "pharm_class_epc": ["beta Lactamase Inhibitor [EPC]"], "pharm_class_moa": ["beta Lactamase Inhibitors [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 BOTTLE (50090-0928-0)", "package_ndc": "50090-0928-0", "marketing_start_date": "20141128"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "50090-0928_26c0009a-da21-48b0-a02a-2161e335a2c7", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "50090-0928", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin and Clavulanate Potassium", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "400 mg/5mL"}, {"name": "CLAVULANIC ACID", "strength": "57 mg/5mL"}], "application_number": "ANDA065191", "marketing_category": "ANDA", "marketing_start_date": "20071201", "listing_expiration_date": "20271231"}