amoxicillin and clavulanate potassium (0781-6139)

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium

Generic Name amoxicillin and clavulanate potassium

Labeler sandoz inc

Dosage Form SUSPENSION

Routes

ORAL

Active Ingredients

amoxicillin 600 mg/5mL, clavulanate potassium 42.9 mg/5mL

Manufacturer

Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-6139

Product ID 0781-6139_a64b73f7-9181-47db-9150-8ca6d2fbd189

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA065358

Listing Expiration 2026-12-31

Marketing Start 2007-08-13

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 07816139

Hyphenated Format 0781-6139

Supplemental Identifiers

RxCUI

617993

UPC

0307816139574

UNII

804826J2HU 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 ANDA065358 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

600 mg/5mL
42.9 mg/5mL

source: ndc

Packaging

200 mL in 1 BOTTLE, DISPENSING (0781-6139-48)
125 mL in 1 BOTTLE, DISPENSING (0781-6139-54)
75 mL in 1 BOTTLE, DISPENSING (0781-6139-57)

source: ndc

Packages (3)

0781-6139-48 200 mL in 1 BOTTLE, DISPENSING (0781-6139-48) 0781-6139-54 125 mL in 1 BOTTLE, DISPENSING (0781-6139-54) 0781-6139-57 75 mL in 1 BOTTLE, DISPENSING (0781-6139-57)

Ingredients (2)

amoxicillin (600 mg/5mL) clavulanate potassium (42.9 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": "a64b73f7-9181-47db-9150-8ca6d2fbd189", "openfda": {"upc": ["0307816139574"], "unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["617993"], "spl_set_id": ["99b7f40a-06f9-4b97-8eee-8e61e5106aad"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 mL in 1 BOTTLE, DISPENSING (0781-6139-48)", "package_ndc": "0781-6139-48", "marketing_start_date": "20070813"}, {"sample": false, "description": "125 mL in 1 BOTTLE, DISPENSING (0781-6139-54)", "package_ndc": "0781-6139-54", "marketing_start_date": "20070813"}, {"sample": false, "description": "75 mL in 1 BOTTLE, DISPENSING (0781-6139-57)", "package_ndc": "0781-6139-57", "marketing_start_date": "20070813"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "0781-6139_a64b73f7-9181-47db-9150-8ca6d2fbd189", "dosage_form": "SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "0781-6139", "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": "600 mg/5mL"}, {"name": "CLAVULANATE POTASSIUM", "strength": "42.9 mg/5mL"}], "application_number": "ANDA065358", "marketing_category": "ANDA", "marketing_start_date": "20070813", "listing_expiration_date": "20261231"}