amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: northstar rxllc
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 northstar rxllc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Northstar RxLLC

Identifiers & Regulatory

Product NDC 16714-014
Product ID 16714-014_3327c23e-bb50-425b-989d-eea2568c99f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065063
Marketing Start 2020-05-01
Marketing End 2026-06-30

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 16714014
Hyphenated Format 16714-014

Supplemental Identifiers

RxCUI
562251 562508 617296
UPC
0316714477015 0316714014012 0316714476018
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 ANDA065063 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 875 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Amoxicillin and Clavulanate Potassium Tablets, USP, 250 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule shaped, debossed GGN5 on one side and plain on the reverse side and contains 250 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 16714-476-01 bottle of 30 film coated tablets Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg: Each film coated tablet, for oral administration, is white, oval-shaped, debossed GGN6 on one side and plain on the reverse side, and contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 16714-477-01 bottle of 20 film coated tablets Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule-shaped, scored and debossed GGN7 on one side and scored on the reverse side and contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 16714-014-01 bottle of 20 film coated tablets NDC 16714-014-02 bottle of 100 film coated tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. KEEP OUT OF THE REACH OF CHILDREN.
  • Tablets 250 mg/125 mg Label NDC 16714-476-01 Rx only Amoxicillin and Clavulanate Potassium Tablets, USP 250 mg/125 mg* 30 Tablets NORTHSTAR 250-125-label
  • Tablets 500 mg/125 mg Label NDC 16714-477-01 Rx only Amoxicillin and Clavulanate Potassium Tablets, USP 500 mg/125 mg* 20 Tablets NORTHSTAR 500-125-label
  • Tablets 875mg / 125mg Label NDC 16714-014-01 Rx only Amoxicillin and Clavulanate Potassium Tablets, USP 875 mg/125 mg* 20 Tablets NORTHSTAR 875-125-label
source: label

Packages (0)

No package records.

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": "3327c23e-bb50-425b-989d-eea2568c99f6", "openfda": {"upc": ["0316714477015", "0316714014012", "0316714476018"], "unii": ["Q42OMW3AT8", "804826J2HU"], "rxcui": ["562251", "562508", "617296"], "spl_set_id": ["d6bff811-a6ea-4e4e-a4eb-b34b966cdb40"], "manufacturer_name": ["Northstar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "16714-014_3327c23e-bb50-425b-989d-eea2568c99f6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "16714-014", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "Northstar RxLLC", "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": "ANDA065063", "marketing_category": "ANDA", "marketing_end_date": "20260630", "marketing_start_date": "20200501"}