Amoxicillin and Clavulanate Potassium NDC 65862-534

Product information

Brand name (proprietary)

Amoxicillin and Clavulanate Potassium

Generic name (nonproprietary)

amoxicillin and clavulanate potassium

Active ingredients

Amoxicillin — 400 mg/5mLClavulanate potassium — 57 mg/5mL

Dosage form

Powder, For suspension

Route

Oral

Labeler

Aurobindo Pharma Limited

Product type

Prescription drug

Marketing category

ANDA — Abbreviated New Drug Application (generic)Application ANDA 201090

Marketing start

Dec 20, 2011

Listing expires

Dec 31, 2027

Other FDA classes

Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)

Identifiers

Product ID 65862-534_8c1bb7b4-1c02-4987-b87c-df3fbc2196abSPL ID 8c1bb7b4-1c02-4987-b87c-df3fbc2196ab

Pharmacologic class

Penicillin-class Antibacterial; beta Lactamase Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N465862053401 followed by a unit qualifier and the quantity Copy

Package 65862-0534-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under ANDA 201090

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.