amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: usantibiotics, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium
Generic Name amoxicillin and clavulanate potassium
Labeler usantibiotics, llc
Dosage Form FOR SUSPENSION
Routes
ORAL
Active Ingredients

amoxicillin 125 mg/5mL, clavulanate potassium 31.25 mg/5mL

Manufacturer
USAntibiotics, LLC

Identifiers & Regulatory

Product NDC 81964-212
Product ID 81964-212_3854c6ad-10f7-dae3-e063-6294a90ae00a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050575
Listing Expiration 2026-12-31
Marketing Start 2022-12-05

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 81964212
Hyphenated Format 81964-212

Supplemental Identifiers

RxCUI
562508 617302 617322
UPC
0381964575835 0381964221145 0381964212037 0381964212051
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 NDA050575 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/5mL
  • 31.25 mg/5mL
source: ndc
Packaging
  • 75 mL in 1 BOTTLE (81964-212-01)
  • 100 mL in 1 BOTTLE (81964-212-03)
  • 150 mL in 1 BOTTLE (81964-212-05)
source: ndc

Packages (3)

81964-212-01 75 mL in 1 BOTTLE (81964-212-01) 81964-212-03 100 mL in 1 BOTTLE (81964-212-03) 81964-212-05 150 mL in 1 BOTTLE (81964-212-05)

Ingredients (2)

amoxicillin (125 mg/5mL) clavulanate potassium (31.25 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": "3854c6ad-10f7-dae3-e063-6294a90ae00a", "openfda": {"upc": ["0381964575835", "0381964221145", "0381964212037", "0381964212051"], "unii": ["Q42OMW3AT8", "804826J2HU"], "rxcui": ["562508", "617302", "617322"], "spl_set_id": ["c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3"], "manufacturer_name": ["USAntibiotics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "75 mL in 1 BOTTLE (81964-212-01)", "package_ndc": "81964-212-01", "marketing_start_date": "20221205"}, {"sample": false, "description": "100 mL in 1 BOTTLE (81964-212-03)", "package_ndc": "81964-212-03", "marketing_start_date": "20221205"}, {"sample": false, "description": "150 mL in 1 BOTTLE (81964-212-05)", "package_ndc": "81964-212-05", "marketing_start_date": "20221205"}], "brand_name": "AMOXICILLIN AND CLAVULANATE POTASSIUM", "product_id": "81964-212_3854c6ad-10f7-dae3-e063-6294a90ae00a", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "81964-212", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "USAntibiotics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMOXICILLIN AND CLAVULANATE POTASSIUM", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "125 mg/5mL"}, {"name": "CLAVULANATE POTASSIUM", "strength": "31.25 mg/5mL"}], "application_number": "NDA050575", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20221205", "listing_expiration_date": "20261231"}