amoxicillin and clavulanate potassium (0781-1943)

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium

Generic Name amoxicillin and clavulanate potassium

Labeler sandoz inc

Dosage Form TABLET, MULTILAYER, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

amoxicillin 562.5 mg/1, amoxicillin sodium 437.5 mg/1, clavulanate potassium 62.5 mg/1

Manufacturer

Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-1943

Product ID 0781-1943_047eb353-1ca4-419b-947c-4d418f87c22a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090227

Listing Expiration 2026-12-31

Marketing Start 2010-04-21

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 07811943

Hyphenated Format 0781-1943

Supplemental Identifiers

RxCUI

617995

UPC

0307811943824

UNII

804826J2HU 544Y3D6MYH 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 ANDA090227 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

562.5 mg/1
437.5 mg/1
62.5 mg/1

source: ndc

Packaging

40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-39)
28 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-82)

source: ndc

Packages (2)

0781-1943-39 40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-39) 0781-1943-82 28 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-82)

Ingredients (3)

amoxicillin (562.5 mg/1) amoxicillin sodium (437.5 mg/1) clavulanate potassium (62.5 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": "047eb353-1ca4-419b-947c-4d418f87c22a", "openfda": {"upc": ["0307811943824"], "unii": ["804826J2HU", "544Y3D6MYH", "Q42OMW3AT8"], "rxcui": ["617995"], "spl_set_id": ["e41387c8-2c74-4990-831f-64dc921ee138"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-39)", "package_ndc": "0781-1943-39", "marketing_start_date": "20100421"}, {"sample": false, "description": "28 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-82)", "package_ndc": "0781-1943-82", "marketing_start_date": "20100421"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "0781-1943_047eb353-1ca4-419b-947c-4d418f87c22a", "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "0781-1943", "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": "562.5 mg/1"}, {"name": "AMOXICILLIN SODIUM", "strength": "437.5 mg/1"}, {"name": "CLAVULANATE POTASSIUM", "strength": "62.5 mg/1"}], "application_number": "ANDA090227", "marketing_category": "ANDA", "marketing_start_date": "20100421", "listing_expiration_date": "20261231"}