amoxicillin and clavulanate potassium (73043-009)

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium

Generic Name amoxicillin and clavulanate potassium

Labeler devatis, inc.

Dosage Form POWDER, FOR SUSPENSION

Routes

ORAL

Active Ingredients

amoxicillin 400 mg/5mL, clavulanate potassium 57 mg/5mL

Manufacturer

Devatis, Inc.

Identifiers & Regulatory

Product NDC 73043-009

Product ID 73043-009_8942c376-8b1a-4716-9b90-de14ab22c4fb

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA210416

Listing Expiration 2026-12-31

Marketing Start 2024-11-01

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 73043009

Hyphenated Format 73043-009

Supplemental Identifiers

RxCUI

617430

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 ANDA210416 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

400 mg/5mL
57 mg/5mL

source: ndc

Packaging

50 mL in 1 BOTTLE (73043-009-01)
75 mL in 1 BOTTLE (73043-009-02)
100 mL in 1 BOTTLE (73043-009-03)

source: ndc

Packages (3)

73043-009-01 50 mL in 1 BOTTLE (73043-009-01) 73043-009-02 75 mL in 1 BOTTLE (73043-009-02) 73043-009-03 100 mL in 1 BOTTLE (73043-009-03)

Ingredients (2)

amoxicillin (400 mg/5mL) clavulanate potassium (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": "8942c376-8b1a-4716-9b90-de14ab22c4fb", "openfda": {"unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["617430"], "spl_set_id": ["90d0aa94-5c32-4fb7-8561-8763810d2847"], "manufacturer_name": ["Devatis, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 BOTTLE (73043-009-01)", "package_ndc": "73043-009-01", "marketing_start_date": "20241101"}, {"sample": false, "description": "75 mL in 1 BOTTLE (73043-009-02)", "package_ndc": "73043-009-02", "marketing_start_date": "20241101"}, {"sample": false, "description": "100 mL in 1 BOTTLE (73043-009-03)", "package_ndc": "73043-009-03", "marketing_start_date": "20241101"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "73043-009_8942c376-8b1a-4716-9b90-de14ab22c4fb", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "73043-009", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "Devatis, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin and Clavulanate Potassium", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "400 mg/5mL"}, {"name": "CLAVULANATE POTASSIUM", "strength": "57 mg/5mL"}], "application_number": "ANDA210416", "marketing_category": "ANDA", "marketing_start_date": "20241101", "listing_expiration_date": "20261231"}