amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: proficient rx lp
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 proficient rx lp
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-060
Product ID 82804-060_0d40bc70-8f47-48c2-a7c6-ba7db9cace74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050720
Listing Expiration 2026-12-31
Marketing Start 2022-11-21

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 82804060
Hyphenated Format 82804-060

Supplemental Identifiers

RxCUI
562508
UPC
0382804060207
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 NDA050720 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 875 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 20 TABLET, COATED in 1 BOTTLE (82804-060-20)
source: ndc

Packages (1)

82804-060-20 20 TABLET, COATED in 1 BOTTLE (82804-060-20)

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": "0d40bc70-8f47-48c2-a7c6-ba7db9cace74", "openfda": {"upc": ["0382804060207"], "unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["562508"], "spl_set_id": ["0d40bc70-8f47-48c2-a7c6-ba7db9cace74"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, COATED in 1 BOTTLE (82804-060-20)", "package_ndc": "82804-060-20", "marketing_start_date": "20240129"}], "brand_name": "AMOXICILLIN AND CLAVULANATE POTASSIUM", "product_id": "82804-060_0d40bc70-8f47-48c2-a7c6-ba7db9cace74", "dosage_form": "TABLET, COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "82804-060", "generic_name": "amoxicillin and clavulanate potassium", "labeler_name": "Proficient Rx LP", "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": "20221121", "listing_expiration_date": "20261231"}