amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: hikma pharmaceuticals usa 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 hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9249
Product ID 0143-9249_46aeb040-bd8f-4fcf-bfb7-98a8efc0a368
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203824
Listing Expiration 2026-12-31
Marketing Start 2016-08-23

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 01439249
Hyphenated Format 0143-9249

Supplemental Identifiers

RxCUI
562508
UPC
0301439249207
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 ANDA203824 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 875 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE (0143-9249-20)
source: ndc

Packages (1)

0143-9249-20 20 TABLET in 1 BOTTLE (0143-9249-20)

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": "46aeb040-bd8f-4fcf-bfb7-98a8efc0a368", "openfda": {"upc": ["0301439249207"], "unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["562508"], "spl_set_id": ["52ab3500-d088-4693-acea-9b83c0843f66"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE (0143-9249-20)", "package_ndc": "0143-9249-20", "marketing_start_date": "20160823"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "0143-9249_46aeb040-bd8f-4fcf-bfb7-98a8efc0a368", "dosage_form": "TABLET", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "0143-9249", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "Hikma Pharmaceuticals USA 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": "ANDA203824", "marketing_category": "ANDA", "marketing_start_date": "20160823", "listing_expiration_date": "20261231"}