amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium
Generic Name amoxicillin and clavulanate potassium
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amoxicillin 875 mg/1, clavulanate potassium 125 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3624
Product ID 70518-3624_47181db1-6286-1bff-e063-6294a90ab0e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065063
Listing Expiration 2026-12-31
Marketing Start 2023-01-27

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 705183624
Hyphenated Format 70518-3624

Supplemental Identifiers

RxCUI
562508
UNII
804826J2HU Q42OMW3AT8

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 ANDA065063 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 875 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 100 POUCH in 1 BOX (70518-3624-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-3624-1)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3624-2)
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3624-3)
source: ndc

Packages (3)

70518-3624-0 100 POUCH in 1 BOX (70518-3624-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-3624-1) 70518-3624-2 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3624-2) 70518-3624-3 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3624-3)

Ingredients (2)

amoxicillin (875 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": "47181db1-6286-1bff-e063-6294a90ab0e2", "openfda": {"unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["562508"], "spl_set_id": ["c88b2b50-c664-43b3-9c37-f134a329dc21"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX (70518-3624-0)  / 1 TABLET, FILM COATED in 1 POUCH (70518-3624-1)", "package_ndc": "70518-3624-0", "marketing_start_date": "20230127"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3624-2)", "package_ndc": "70518-3624-2", "marketing_start_date": "20250212"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3624-3)", "package_ndc": "70518-3624-3", "marketing_start_date": "20250313"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "70518-3624_47181db1-6286-1bff-e063-6294a90ab0e2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "70518-3624", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin and Clavulanate Potassium", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "875 mg/1"}, {"name": "CLAVULANATE POTASSIUM", "strength": "125 mg/1"}], "application_number": "ANDA065063", "marketing_category": "ANDA", "marketing_start_date": "20230127", "listing_expiration_date": "20261231"}