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 POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

amoxicillin 250 mg/5mL, clavulanate potassium 62.5 mg/5mL

Manufacturer
Devatis, Inc.

Identifiers & Regulatory

Product NDC 73043-010
Product ID 73043-010_e5eda5f6-317c-43ac-b1d7-c6ce635593da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210374
Listing Expiration 2026-12-31
Marketing Start 2024-07-05

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 73043010
Hyphenated Format 73043-010

Supplemental Identifiers

RxCUI
617322
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 ANDA210374 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
  • 62.5 mg/5mL
source: ndc
Packaging
  • 75 mL in 1 BOTTLE (73043-010-01)
  • 100 mL in 1 BOTTLE (73043-010-02)
  • 150 mL in 1 BOTTLE (73043-010-03)
source: ndc

Packages (3)

73043-010-01 75 mL in 1 BOTTLE (73043-010-01) 73043-010-02 100 mL in 1 BOTTLE (73043-010-02) 73043-010-03 150 mL in 1 BOTTLE (73043-010-03)

Ingredients (2)

amoxicillin (250 mg/5mL) clavulanate potassium (62.5 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": "e5eda5f6-317c-43ac-b1d7-c6ce635593da", "openfda": {"unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["617322"], "spl_set_id": ["b0b2e164-e70d-471f-92ce-abdac6cb405f"], "manufacturer_name": ["Devatis, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "75 mL in 1 BOTTLE (73043-010-01)", "package_ndc": "73043-010-01", "marketing_start_date": "20240815"}, {"sample": false, "description": "100 mL in 1 BOTTLE (73043-010-02)", "package_ndc": "73043-010-02", "marketing_start_date": "20240901"}, {"sample": false, "description": "150 mL in 1 BOTTLE (73043-010-03)", "package_ndc": "73043-010-03", "marketing_start_date": "20240705"}], "brand_name": "amoxicillin and clavulanate potassium", "product_id": "73043-010_e5eda5f6-317c-43ac-b1d7-c6ce635593da", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "73043-010", "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": "250 mg/5mL"}, {"name": "CLAVULANATE POTASSIUM", "strength": "62.5 mg/5mL"}], "application_number": "ANDA210374", "marketing_category": "ANDA", "marketing_start_date": "20240705", "listing_expiration_date": "20261231"}