augmentin

Generic: amoxicillin and clavulanate potassium

Labeler: allegis holdings, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

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

Manufacturer
Allegis Holdings, LLC

Identifiers & Regulatory

Product NDC 71297-240
Product ID 71297-240_18975386-c292-a0cb-e063-6294a90aed18
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050575
Listing Expiration 2026-12-31
Marketing Start 2023-09-01

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 71297240
Hyphenated Format 71297-240

Supplemental Identifiers

RxCUI
617302 617333
UPC
0371297240364 0371297240340
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 augmentin (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 (71297-240-34)
  • 100 mL in 1 BOTTLE (71297-240-35)
  • 150 mL in 1 BOTTLE (71297-240-36)
source: ndc

Packages (3)

71297-240-34 75 mL in 1 BOTTLE (71297-240-34) 71297-240-35 100 mL in 1 BOTTLE (71297-240-35) 71297-240-36 150 mL in 1 BOTTLE (71297-240-36)

Ingredients (2)

amoxicillin (125 mg/5mL) clavulanate potassium (31.25 mg/5mL)

Linked Drug Pages (1)

Augmentin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "18975386-c292-a0cb-e063-6294a90aed18", "openfda": {"upc": ["0371297240364", "0371297240340"], "unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["617302", "617333"], "spl_set_id": ["04a31a42-d79e-bbb4-e063-6394a90a63ee"], "manufacturer_name": ["Allegis Holdings, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "75 mL in 1 BOTTLE (71297-240-34)", "package_ndc": "71297-240-34", "marketing_start_date": "20240220"}, {"sample": false, "description": "100 mL in 1 BOTTLE (71297-240-35)", "package_ndc": "71297-240-35", "marketing_start_date": "20230901"}, {"sample": false, "description": "150 mL in 1 BOTTLE (71297-240-36)", "package_ndc": "71297-240-36", "marketing_start_date": "20230901"}], "brand_name": "Augmentin", "product_id": "71297-240_18975386-c292-a0cb-e063-6294a90aed18", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "71297-240", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "Allegis Holdings, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Augmentin", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "125 mg/5mL"}, {"name": "CLAVULANATE POTASSIUM", "strength": "31.25 mg/5mL"}], "application_number": "NDA050575", "marketing_category": "NDA", "marketing_start_date": "20230901", "listing_expiration_date": "20261231"}