amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: proficient rx lp
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 proficient rx lp
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

amoxicillin 400 mg/5mL, clavulanic acid 57 mg/5mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-826
Product ID 63187-826_2797b8b4-eac7-419e-b7da-a6e7493661c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065191
Listing Expiration 2026-12-31
Marketing Start 2007-12-01

Pharmacologic Class

Established (EPC)
beta lactamase inhibitor [epc]
Mechanism of Action
beta lactamase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187826
Hyphenated Format 63187-826

Supplemental Identifiers

RxCUI
617430
UNII
804826J2HU 23521W1S24
NUI
N0000175930 N0000000202

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 ANDA065191 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/5mL
  • 57 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (63187-826-00)
source: ndc

Packages (1)

63187-826-00 100 mL in 1 BOTTLE (63187-826-00)

Ingredients (2)

amoxicillin (400 mg/5mL) clavulanic acid (57 mg/5mL)

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": "2797b8b4-eac7-419e-b7da-a6e7493661c7", "openfda": {"nui": ["N0000175930", "N0000000202"], "unii": ["804826J2HU", "23521W1S24"], "rxcui": ["617430"], "spl_set_id": ["4655e0ea-f7d5-4f7c-bf7b-266337bc05b8"], "pharm_class_epc": ["beta Lactamase Inhibitor [EPC]"], "pharm_class_moa": ["beta Lactamase Inhibitors [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (63187-826-00)", "package_ndc": "63187-826-00", "marketing_start_date": "20170301"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "63187-826_2797b8b4-eac7-419e-b7da-a6e7493661c7", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "63187-826", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin and Clavulanate Potassium", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "400 mg/5mL"}, {"name": "CLAVULANIC ACID", "strength": "57 mg/5mL"}], "application_number": "ANDA065191", "marketing_category": "ANDA", "marketing_start_date": "20071201", "listing_expiration_date": "20261231"}