amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: american health packaging
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 american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amoxicillin 250 mg/1, clavulanate potassium 125 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-781
Product ID 60687-781_4c5fbf4c-ad51-58fd-e063-6294a90a8133
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091569
Marketing Start 2024-07-26
Marketing End 2026-11-30

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 60687781
Hyphenated Format 60687-781

Supplemental Identifiers

RxCUI
562251 562508 617296
UNII
Q42OMW3AT8 804826J2HU

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 ANDA091569 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 CARTON (60687-781-94) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-781-11)
source: ndc

Packages (1)

60687-781-94 20 BLISTER PACK in 1 CARTON (60687-781-94) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-781-11)

Ingredients (2)

amoxicillin (250 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": "4c5fbf4c-ad51-58fd-e063-6294a90a8133", "openfda": {"unii": ["Q42OMW3AT8", "804826J2HU"], "rxcui": ["562251", "562508", "617296"], "spl_set_id": ["4966a3f2-eed2-4081-ba88-310a3d1964b4"], "manufacturer_name": ["American Health Packaging"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 CARTON (60687-781-94)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-781-11)", "package_ndc": "60687-781-94", "marketing_end_date": "20261130", "marketing_start_date": "20240726"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "60687-781_4c5fbf4c-ad51-58fd-e063-6294a90a8133", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "60687-781", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin and Clavulanate Potassium", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "250 mg/1"}, {"name": "CLAVULANATE POTASSIUM", "strength": "125 mg/1"}], "application_number": "ANDA091569", "marketing_category": "ANDA", "marketing_end_date": "20261130", "marketing_start_date": "20240726"}