amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: devatis, 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 devatis, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amoxicillin 500 mg/1, clavulanate potassium 125 mg/1

Manufacturer
Devatis, Inc.

Identifiers & Regulatory

Product NDC 73043-007
Product ID 73043-007_a51715ae-3a5c-4502-a9d9-a7469d5adc69
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209992
Listing Expiration 2026-12-31
Marketing Start 2024-11-01

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 73043007
Hyphenated Format 73043-007

Supplemental Identifiers

RxCUI
562508 617296
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 ANDA209992 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (73043-007-20)
source: ndc

Packages (1)

73043-007-20 20 TABLET, FILM COATED in 1 BOTTLE (73043-007-20)

Ingredients (2)

amoxicillin (500 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": "a51715ae-3a5c-4502-a9d9-a7469d5adc69", "openfda": {"unii": ["Q42OMW3AT8", "804826J2HU"], "rxcui": ["562508", "617296"], "spl_set_id": ["d25c8190-3690-4ce6-a525-21850754224d"], "manufacturer_name": ["Devatis, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (73043-007-20)", "package_ndc": "73043-007-20", "marketing_start_date": "20241101"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "73043-007_a51715ae-3a5c-4502-a9d9-a7469d5adc69", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "73043-007", "generic_name": "amoxicillin and clavulanate potassium", "labeler_name": "Devatis, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin and Clavulanate Potassium", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "500 mg/1"}, {"name": "CLAVULANATE POTASSIUM", "strength": "125 mg/1"}], "application_number": "ANDA209992", "marketing_category": "ANDA", "marketing_start_date": "20241101", "listing_expiration_date": "20261231"}