amoxicillin and clavulanate potassium (0781-1831)

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium

Generic Name amoxicillin and clavulanate potassium

Labeler sandoz inc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

amoxicillin 500 mg/1, clavulanate potassium 125 mg/1

Manufacturer

Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-1831

Product ID 0781-1831_6a6233c9-2bba-4d8c-9bfa-e5c5055cf91f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA065064

Listing Expiration 2026-12-31

Marketing Start 2002-03-15

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 07811831

Hyphenated Format 0781-1831

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 ANDA065064 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

500 mg/1
125 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE (0781-1831-01)
100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0781-1831-13)
20 TABLET, FILM COATED in 1 BOTTLE (0781-1831-20)

source: ndc

Packages (3)

0781-1831-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-1831-01) 0781-1831-13 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0781-1831-13) 0781-1831-20 20 TABLET, FILM COATED in 1 BOTTLE (0781-1831-20)

Ingredients (2)

amoxicillin (500 mg/1) clavulanate potassium (125 mg/1)

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 TABLET, FILM COATED in 1 BOTTLE (0781-1831-01)", "package_ndc": "0781-1831-01", "marketing_start_date": "20220920"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0781-1831-13)", "package_ndc": "0781-1831-13", "marketing_start_date": "20020315"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (0781-1831-20)", "package_ndc": "0781-1831-20", "marketing_start_date": "20020315"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "0781-1831_6a6233c9-2bba-4d8c-9bfa-e5c5055cf91f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "0781-1831", "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": "500 mg/1"}, {"name": "CLAVULANATE POTASSIUM", "strength": "125 mg/1"}], "application_number": "ANDA065064", "marketing_category": "ANDA", "marketing_start_date": "20020315", "listing_expiration_date": "20261231"}