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, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
USAntibiotics, LLC

Identifiers & Regulatory

Product NDC 81964-220
Product ID 81964-220_45c6020c-fd42-d920-e063-6294a90a67e0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050785
Listing Expiration 2026-12-31
Marketing Start 2025-12-15

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 81964220
Hyphenated Format 81964-220

Supplemental Identifiers

RxCUI
617995
UPC
0381964220285 0381964220407
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 NDA050785 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 562.5 mg/1
  • 437.5 mg/1
  • 62.5 mg/1
source: ndc
Packaging
  • 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-28)
  • 40 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-40)
source: ndc

Packages (2)

81964-220-28 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-28) 81964-220-40 40 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-40)

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": "45c6020c-fd42-d920-e063-6294a90a67e0", "openfda": {"upc": ["0381964220285", "0381964220407"], "unii": ["804826J2HU", "544Y3D6MYH", "Q42OMW3AT8"], "rxcui": ["617995"], "spl_set_id": ["45c60b69-1b65-01ed-e063-6294a90a57be"], "manufacturer_name": ["USAntibiotics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-28)", "package_ndc": "81964-220-28", "marketing_start_date": "20251215"}, {"sample": false, "description": "40 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-40)", "package_ndc": "81964-220-40", "marketing_start_date": "20251215"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "81964-220_45c6020c-fd42-d920-e063-6294a90a67e0", "dosage_form": "TABLET, FILM COATED, 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": "81964-220", "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": "562.5 mg/1"}, {"name": "AMOXICILLIN SODIUM", "strength": "437.5 mg/1"}, {"name": "CLAVULANATE POTASSIUM", "strength": "62.5 mg/1"}], "application_number": "NDA050785", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20251215", "listing_expiration_date": "20261231"}