amoxicillin and clavulanate potassium (42571-161)

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium

Generic Name amoxicillin and clavulanate potassium

Labeler micro labs limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

amoxicillin 500 mg/1, clavulanate potassium 125 mg/1

Manufacturer

Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-161

Product ID 42571-161_3a71d6d7-6111-a0f8-e063-6394a90aa0e7

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA205707

Listing Expiration 2026-12-31

Marketing Start 2017-03-01

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 42571161

Hyphenated Format 42571-161

Supplemental Identifiers

RxCUI

562251 562508 617296

UPC

0342571161422 0342571160302 0342571162429

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 ANDA205707 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

500 mg/1
125 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE (42571-161-01)
10 BLISTER PACK in 1 CARTON (42571-161-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-161-32)
20 TABLET, FILM COATED in 1 BOTTLE (42571-161-42)

source: ndc

Packages (3)

42571-161-01 100 TABLET, FILM COATED in 1 BOTTLE (42571-161-01) 42571-161-11 10 BLISTER PACK in 1 CARTON (42571-161-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-161-32) 42571-161-42 20 TABLET, FILM COATED in 1 BOTTLE (42571-161-42)

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": "3a71d6d7-6111-a0f8-e063-6394a90aa0e7", "openfda": {"upc": ["0342571161422", "0342571160302", "0342571162429"], "unii": ["Q42OMW3AT8", "804826J2HU"], "rxcui": ["562251", "562508", "617296"], "spl_set_id": ["0c2d1fbc-f80c-4737-a15e-9cfa6bf99769"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (42571-161-01)", "package_ndc": "42571-161-01", "marketing_start_date": "20170301"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (42571-161-11)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-161-32)", "package_ndc": "42571-161-11", "marketing_start_date": "20170301"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (42571-161-42)", "package_ndc": "42571-161-42", "marketing_start_date": "20170301"}], "brand_name": "AMOXICILLIN AND CLAVULANATE POTASSIUM", "product_id": "42571-161_3a71d6d7-6111-a0f8-e063-6394a90aa0e7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "42571-161", "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": "500 mg/1"}, {"name": "CLAVULANATE POTASSIUM", "strength": "125 mg/1"}], "application_number": "ANDA205707", "marketing_category": "ANDA", "marketing_start_date": "20170301", "listing_expiration_date": "20261231"}