amoxicillin and clavulanate potassium (68788-8317)

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium

Generic Name amoxicillin and clavulanate potassium

Labeler preferred pharmaceuticals inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8317

Product ID 68788-8317_95ca3695-cb4f-4ce9-8f68-a22e2d72d17c

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA091569

Listing Expiration 2027-12-31

Marketing Start 2022-12-23

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 687888317

Hyphenated Format 68788-8317

Supplemental Identifiers

RxCUI

617296

UNII

804826J2HU Q42OMW3AT8

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 ANDA091569 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

500 mg/1
125 mg/1

source: ndc

Packaging

20 TABLET, FILM COATED in 1 BOTTLE (68788-8317-2)

source: ndc

Packages (1)

68788-8317-2 20 TABLET, FILM COATED in 1 BOTTLE (68788-8317-2)

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": "95ca3695-cb4f-4ce9-8f68-a22e2d72d17c", "openfda": {"unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["617296"], "spl_set_id": ["d23b6952-5e4c-4103-9fe0-a916b1e2e1b9"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68788-8317-2)", "package_ndc": "68788-8317-2", "marketing_start_date": "20221223"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "68788-8317_95ca3695-cb4f-4ce9-8f68-a22e2d72d17c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "68788-8317", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "Preferred Pharmaceuticals 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": "ANDA091569", "marketing_category": "ANDA", "marketing_start_date": "20221223", "listing_expiration_date": "20271231"}