amoxicillin and clavulanate potassium (43063-377)

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium

Generic Name amoxicillin and clavulanate potassium

Labeler pd-rx pharmaceuticals, inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-377

Product ID 43063-377_41379c75-8030-e15f-e063-6394a90a6a3b

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA065096

Listing Expiration 2026-12-31

Marketing Start 2002-10-31

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 43063377

Hyphenated Format 43063-377

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 ANDA065096 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

875 mg/1
125 mg/1

source: ndc

Packaging

2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-377-02)

source: ndc

Packages (1)

43063-377-02 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-377-02)

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": "41379c75-8030-e15f-e063-6394a90a6a3b", "openfda": {"unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["562508"], "spl_set_id": ["416fa58c-88fa-42aa-9195-74aeba641577"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-377-02)", "package_ndc": "43063-377-02", "marketing_start_date": "20120803"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "43063-377_41379c75-8030-e15f-e063-6394a90a6a3b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "43063-377", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "PD-Rx Pharmaceuticals, 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": "ANDA065096", "marketing_category": "ANDA", "marketing_start_date": "20021031", "listing_expiration_date": "20261231"}