amoxicillin and clavulanate potassium (0781-6104)

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium

Generic Name amoxicillin and clavulanate potassium

Labeler sandoz inc

Dosage Form POWDER, FOR SUSPENSION

Routes

ORAL

Active Ingredients

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

Manufacturer

Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-6104

Product ID 0781-6104_6a6233c9-2bba-4d8c-9bfa-e5c5055cf91f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA065066

Listing Expiration 2026-12-31

Marketing Start 2002-06-05

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 07816104

Hyphenated Format 0781-6104

Supplemental Identifiers

RxCUI

562251 562508 617296 617423 617430

UPC

0307816102462 0307811831206 0307811874319 0307811852201

UNII

Q42OMW3AT8 804826J2HU

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 ANDA065066 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

400 mg/5mL
57 mg/5mL

source: ndc

Packaging

100 mL in 1 BOTTLE (0781-6104-46)
50 mL in 1 BOTTLE (0781-6104-52)
75 mL in 1 BOTTLE (0781-6104-57)

source: ndc

Packages (3)

0781-6104-46 100 mL in 1 BOTTLE (0781-6104-46) 0781-6104-52 50 mL in 1 BOTTLE (0781-6104-52) 0781-6104-57 75 mL in 1 BOTTLE (0781-6104-57)

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": "6a6233c9-2bba-4d8c-9bfa-e5c5055cf91f", "openfda": {"upc": ["0307816102462", "0307811831206", "0307811874319", "0307811852201"], "unii": ["Q42OMW3AT8", "804826J2HU"], "rxcui": ["562251", "562508", "617296", "617423", "617430"], "spl_set_id": ["7cba82f0-9886-46e9-8dbd-43a448aade29"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (0781-6104-46)", "package_ndc": "0781-6104-46", "marketing_start_date": "20020605"}, {"sample": false, "description": "50 mL in 1 BOTTLE (0781-6104-52)", "package_ndc": "0781-6104-52", "marketing_start_date": "20231218"}, {"sample": false, "description": "75 mL in 1 BOTTLE (0781-6104-57)", "package_ndc": "0781-6104-57", "marketing_start_date": "20231218"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "0781-6104_6a6233c9-2bba-4d8c-9bfa-e5c5055cf91f", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "0781-6104", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "Sandoz 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": "ANDA065066", "marketing_category": "ANDA", "marketing_start_date": "20020605", "listing_expiration_date": "20261231"}