amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: sportpharm, inc. dba sportpharm
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium
Generic Name amoxicillin and clavulanate potassium
Labeler sportpharm, inc. dba sportpharm
Dosage Form TABLET, MULTILAYER, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
Sportpharm, Inc. dba Sportpharm

Identifiers & Regulatory

Product NDC 85766-123
Product ID 85766-123_42e6d90d-c118-e1ca-e063-6294a90ac757
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090227
Listing Expiration 2026-12-31
Marketing Start 2010-04-21

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 85766123
Hyphenated Format 85766-123

Supplemental Identifiers

RxCUI
617995
UNII
804826J2HU 544Y3D6MYH 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 ANDA090227 (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, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (85766-123-28)
source: ndc

Packages (1)

85766-123-28 28 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (85766-123-28)

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": "42e6d90d-c118-e1ca-e063-6294a90ac757", "openfda": {"unii": ["804826J2HU", "544Y3D6MYH", "Q42OMW3AT8"], "rxcui": ["617995"], "spl_set_id": ["cd7d2c0c-bf58-457a-b3d1-bb4c167cd127"], "manufacturer_name": ["Sportpharm, Inc. dba Sportpharm"]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (85766-123-28)", "package_ndc": "85766-123-28", "marketing_start_date": "20251106"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "85766-123_42e6d90d-c118-e1ca-e063-6294a90ac757", "dosage_form": "TABLET, MULTILAYER, 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": "85766-123", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "Sportpharm, Inc. dba Sportpharm", "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": "ANDA090227", "marketing_category": "ANDA", "marketing_start_date": "20100421", "listing_expiration_date": "20261231"}