Amoxicillin and Clavulanate Potassium NDC 80425-0180

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0180Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0180Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
80425-0180-1	80425018001	20 TABLET, FILM COATED in 1 BOTTLE (80425-0180-1)Marketed from Mar 1, 2017
80425-0180-2	80425018002	30 TABLET, FILM COATED in 1 BOTTLE (80425-0180-2)Marketed from Mar 1, 2017
80425-0180-3	80425018003	14 TABLET, FILM COATED in 1 BOTTLE (80425-0180-3)Marketed from Feb 2, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Amoxicillin and Clavulanate Potassium
Generic name (nonproprietary): amoxicillin and clavulanate potassium
Active ingredients: Clavulanate potassium — 125 mg/1Amoxicillin — 875 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204755
Marketing start: Mar 1, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 80425-0180_2d324dc5-6376-be6b-e063-6394a90a82ddSPL ID 2d324dc5-6376-be6b-e063-6394a90a82ddSPL set ID d294e4a2-8ce7-418d-e053-2a95a90ab10bRxCUI 562508UNII Q42OMW3AT8, 804826J2HU
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

N480425018001 followed by a unit qualifier and the quantity

Package 80425-0180-01. 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

Current FDA label (SPL), effective Feb 2, 2025.

Indications (excerpt from the label)

1. Indications and Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets USP, and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets USP is a combination penicillin-class antiba…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204755

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

FDA NDC Directory listings under ANDA 204755
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-331
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Medsource Pharmaceuticals	45865-227
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	82868-002
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-2263
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2917
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-005
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7531
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3967
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3402
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4549
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Micro Labs Limited	42571-162
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Sportpharm LLC	85766-171
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4224
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2434