amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: usantibiotics, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium
Generic Name amoxicillin and clavulanate potassium
Labeler usantibiotics, llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

amoxicillin 875 mg/1, clavulanate potassium 125 mg/1

Manufacturer
USAntibiotics, LLC

Identifiers & Regulatory

Product NDC 81964-575
Product ID 81964-575_3854c6ad-10f7-dae3-e063-6294a90ae00a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050720
Listing Expiration 2026-12-31
Marketing Start 2025-07-02

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 81964575
Hyphenated Format 81964-575

Supplemental Identifiers

RxCUI
562508 617302 617322
UPC
0381964575835 0381964221145 0381964212037 0381964212051
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 NDA050720 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 875 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 180 TABLET, COATED in 1 BOTTLE (81964-575-83)
source: ndc

Packages (1)

81964-575-83 180 TABLET, COATED in 1 BOTTLE (81964-575-83)

Ingredients (2)

amoxicillin (875 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": "3854c6ad-10f7-dae3-e063-6294a90ae00a", "openfda": {"upc": ["0381964575835", "0381964221145", "0381964212037", "0381964212051"], "unii": ["Q42OMW3AT8", "804826J2HU"], "rxcui": ["562508", "617302", "617322"], "spl_set_id": ["c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3"], "manufacturer_name": ["USAntibiotics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, COATED in 1 BOTTLE (81964-575-83)", "package_ndc": "81964-575-83", "marketing_start_date": "20250702"}], "brand_name": "AMOXICILLIN AND CLAVULANATE POTASSIUM", "product_id": "81964-575_3854c6ad-10f7-dae3-e063-6294a90ae00a", "dosage_form": "TABLET, COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "81964-575", "generic_name": "amoxicillin and clavulanate potassium", "labeler_name": "USAntibiotics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMOXICILLIN AND CLAVULANATE POTASSIUM", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "875 mg/1"}, {"name": "CLAVULANATE POTASSIUM", "strength": "125 mg/1"}], "application_number": "NDA050720", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20250702", "listing_expiration_date": "20261231"}