amoxicillin and clavulanate potassium (68071-1619)

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium

Generic Name amoxicillin and clavulanate potassium

Labeler nucare pharmaceuticals,inc.

Dosage Form POWDER, FOR SUSPENSION

Routes

ORAL

Active Ingredients

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

Manufacturer

NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-1619

Product ID 68071-1619_1d4c3bbf-43f9-8590-e063-6294a90adebb

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 680711619

Hyphenated Format 68071-1619

Supplemental Identifiers

RxCUI

617430

UPC

0368071161915

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 (68071-1619-1)

source: ndc

Packages (1)

68071-1619-1 100 mL in 1 BOTTLE (68071-1619-1)

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": "1d4c3bbf-43f9-8590-e063-6294a90adebb", "openfda": {"nui": ["N0000175930", "N0000000202"], "upc": ["0368071161915"], "unii": ["804826J2HU", "23521W1S24"], "rxcui": ["617430"], "spl_set_id": ["5d074fe6-1ee0-40d8-e053-2a91aa0a7549"], "pharm_class_epc": ["beta Lactamase Inhibitor [EPC]"], "pharm_class_moa": ["beta Lactamase Inhibitors [MoA]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (68071-1619-1)", "package_ndc": "68071-1619-1", "marketing_start_date": "20171102"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "68071-1619_1d4c3bbf-43f9-8590-e063-6294a90adebb", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "68071-1619", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "NuCare Pharmaceuticals,Inc.", "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"}