amoxicillin and clavulanate potassium (42571-395)

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium

Generic Name amoxicillin and clavulanate potassium

Labeler micro labs limited

Dosage Form FOR SUSPENSION

Routes

ORAL

Active Ingredients

amoxicillin 600 mg/5mL, clavulanate potassium 42.9 mg/5mL

Manufacturer

Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-395

Product ID 42571-395_2bd14acf-1437-ec8d-e063-6394a90adc4f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA217805

Listing Expiration 2026-12-31

Marketing Start 2024-04-01

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 42571395

Hyphenated Format 42571-395

Supplemental Identifiers

RxCUI

617993

UPC

0342571395469

UNII

804826J2HU Q42OMW3AT8

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 ANDA217805 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

600 mg/5mL
42.9 mg/5mL

source: ndc

Packaging

75 mL in 1 BOTTLE (42571-395-46)
125 mL in 1 BOTTLE (42571-395-70)
200 mL in 1 BOTTLE (42571-395-77)

source: ndc

Packages (3)

42571-395-46 75 mL in 1 BOTTLE (42571-395-46) 42571-395-70 125 mL in 1 BOTTLE (42571-395-70) 42571-395-77 200 mL in 1 BOTTLE (42571-395-77)

Ingredients (2)

amoxicillin (600 mg/5mL) clavulanate potassium (42.9 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": "2bd14acf-1437-ec8d-e063-6394a90adc4f", "openfda": {"upc": ["0342571395469"], "unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["617993"], "spl_set_id": ["26992a71-e4a0-4e41-aa3c-3219868c2226"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "75 mL in 1 BOTTLE (42571-395-46)", "package_ndc": "42571-395-46", "marketing_start_date": "20240401"}, {"sample": false, "description": "125 mL in 1 BOTTLE (42571-395-70)", "package_ndc": "42571-395-70", "marketing_start_date": "20240401"}, {"sample": false, "description": "200 mL in 1 BOTTLE (42571-395-77)", "package_ndc": "42571-395-77", "marketing_start_date": "20240401"}], "brand_name": "Amoxicillin and clavulanate potassium", "product_id": "42571-395_2bd14acf-1437-ec8d-e063-6394a90adc4f", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "42571-395", "generic_name": "Amoxicillin and clavulanate potassium", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin and clavulanate potassium", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "600 mg/5mL"}, {"name": "CLAVULANATE POTASSIUM", "strength": "42.9 mg/5mL"}], "application_number": "ANDA217805", "marketing_category": "ANDA", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}