NDC 51655-158

Amoxicillan and clavulanate potassium

Amoxicillan And Clavulanate Potassium

Amoxicillan and clavulanate potassium is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Northwind Pharmaceuticals, Llc. The primary component is Amoxicillin; Clavulanate Potassium.

• Product ID: 51655-158_c07e72b4-3106-4cd3-acd8-365121c5e687
• NDC: 51655-158
• Product Type: Human Prescription Drug
• Proprietary Name: Amoxicillan and clavulanate potassium
• Generic Name: Amoxicillan And Clavulanate Potassium
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-07-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091569
• Labeler Name: Northwind Pharmaceuticals, LLC
• Substance Name: AMOXICILLIN; CLAVULANATE POTASSIUM
• Active Ingredient Strength: 500 mg/1; mg/1
• Pharm Classes: Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 51655-158-03

3 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-158-03)

• Marketing Start Date: 2014-07-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51655-158-03 [51655015803]

Amoxicillan and clavulanate potassium TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA091569
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-07-18
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
AMOXICILLIN	500 mg/1

OpenFDA Data

• SPL SET ID: 909c85de-c076-4444-b63c-cd8bdc556f36
• Manufacturer:
  • Northwind Pharmaceuticals, LLC
• UNII:
  • Q42OMW3AT8
  • 804826J2HU
• RxNorm Concept Unique ID - RxCUI:
  • 617296

Pharmacological Class

• Penicillin-class Antibacterial [EPC]
• Penicillins [CS]
• beta Lactamase Inhibitor [EPC]
• beta Lactamase Inhibitors [MoA]