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 500 mg/1, clavulanate potassium 125 mg/1

Manufacturer
ASCLEMED USA INC.

Identifiers & Regulatory

Product NDC 76420-455
Product ID 76420-455_49ee4d0b-4d68-ab0c-e063-6294a90a3b7a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091569
Listing Expiration 2027-12-31
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 76420455
Hyphenated Format 76420-455

Supplemental Identifiers

RxCUI
562508 617296
UNII
Q42OMW3AT8 804826J2HU

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 ANDA091569 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (76420-455-20)
source: ndc

Packages (1)

76420-455-20 20 TABLET, FILM COATED in 1 BOTTLE (76420-455-20)

Ingredients (2)

amoxicillin (500 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": "49ee4d0b-4d68-ab0c-e063-6294a90a3b7a", "openfda": {"unii": ["Q42OMW3AT8", "804826J2HU"], "rxcui": ["562508", "617296"], "spl_set_id": ["65168aaf-e800-45f1-9572-ddf430b1ff3a"], "manufacturer_name": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (76420-455-20)", "package_ndc": "76420-455-20", "marketing_start_date": "20250813"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "76420-455_49ee4d0b-4d68-ab0c-e063-6294a90a3b7a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "76420-455", "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": "500 mg/1"}, {"name": "CLAVULANATE POTASSIUM", "strength": "125 mg/1"}], "application_number": "ANDA091569", "marketing_category": "ANDA", "marketing_start_date": "20120120", "listing_expiration_date": "20271231"}