amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: asclemed usa, inc.
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 asclemed usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-607
Product ID 76420-607_04ab2de4-f463-1b52-e063-6394a90a5fc6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091568
Listing Expiration 2026-12-31
Marketing Start 2012-01-20

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 76420607
Hyphenated Format 76420-607

Supplemental Identifiers

RxCUI
562508
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 ANDA091568 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 875 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76420-607-01)
  • 20 TABLET, FILM COATED in 1 BOTTLE (76420-607-20)
source: ndc

Packages (2)

76420-607-01 100 TABLET, FILM COATED in 1 BOTTLE (76420-607-01) 76420-607-20 20 TABLET, FILM COATED in 1 BOTTLE (76420-607-20)

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": "04ab2de4-f463-1b52-e063-6394a90a5fc6", "openfda": {"unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["562508"], "spl_set_id": ["f14a8008-c0ff-4628-af99-e5f07b19df71"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76420-607-01)", "package_ndc": "76420-607-01", "marketing_start_date": "20230906"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (76420-607-20)", "package_ndc": "76420-607-20", "marketing_start_date": "20230906"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "76420-607_04ab2de4-f463-1b52-e063-6394a90a5fc6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "76420-607", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "Asclemed USA, Inc.", "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": "ANDA091568", "marketing_category": "ANDA", "marketing_start_date": "20120120", "listing_expiration_date": "20261231"}