amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: teva 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 teva pharmaceuticals usa, inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

amoxicillin 600 mg/5mL, clavulanate potassium 42.9 mg/5mL

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-8675
Product ID 0093-8675_2faf9b29-5df4-4f3c-84d9-6866f91b87e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065162
Listing Expiration 2027-12-31
Marketing Start 2004-09-23

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 00938675
Hyphenated Format 0093-8675

Supplemental Identifiers

RxCUI
617993
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 ANDA065162 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/5mL
  • 42.9 mg/5mL
source: ndc
Packaging
  • 200 mL in 1 BOTTLE (0093-8675-74)
  • 125 mL in 1 BOTTLE (0093-8675-75)
  • 75 mL in 1 BOTTLE (0093-8675-78)
source: ndc

Packages (3)

0093-8675-74 200 mL in 1 BOTTLE (0093-8675-74) 0093-8675-75 125 mL in 1 BOTTLE (0093-8675-75) 0093-8675-78 75 mL in 1 BOTTLE (0093-8675-78)

Ingredients (2)

amoxicillin (600 mg/5mL) clavulanate potassium (42.9 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": "2faf9b29-5df4-4f3c-84d9-6866f91b87e8", "openfda": {"unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["617993"], "spl_set_id": ["e83f43dd-f79e-4166-9bee-9427e235c876"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 mL in 1 BOTTLE (0093-8675-74)", "package_ndc": "0093-8675-74", "marketing_start_date": "20040923"}, {"sample": false, "description": "125 mL in 1 BOTTLE (0093-8675-75)", "package_ndc": "0093-8675-75", "marketing_start_date": "20040923"}, {"sample": false, "description": "75 mL in 1 BOTTLE (0093-8675-78)", "package_ndc": "0093-8675-78", "marketing_start_date": "20040923"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "0093-8675_2faf9b29-5df4-4f3c-84d9-6866f91b87e8", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "0093-8675", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin and Clavulanate Potassium", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "600 mg/5mL"}, {"name": "CLAVULANATE POTASSIUM", "strength": "42.9 mg/5mL"}], "application_number": "ANDA065162", "marketing_category": "ANDA", "marketing_start_date": "20040923", "listing_expiration_date": "20271231"}