Amoxicillin and Clavulanate Potassium NDC 63187-803

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-803Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0803Add 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	Copy
63187-803-20	63187080320	20 TABLET, FILM COATED in 1 BOTTLE (63187-803-20)Marketed from Jan 2, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: Amoxicillin — 500 mg/1Clavulanate potassium — 125 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065064
Marketing start: Mar 15, 2002
Listing expires: Dec 31, 2026
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 63187-803_c7442c05-30ea-427d-b832-611e0d1c392fSPL ID c7442c05-30ea-427d-b832-611e0d1c392fSPL set ID 01b30abb-db63-4257-9fe2-9107bb0bd69cRxCUI 617296UNII 804826J2HU, Q42OMW3AT8
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

N463187080320 followed by a unit qualifier and the quantity

Package 63187-0803-20. 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 Nov 1, 2019.

Indications (excerpt from the label)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium 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, for oral suspension, USP, and chewable tablets, USP are a combination penici…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065064

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

FDA NDC Directory listings under ANDA 065064
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin and Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Sandoz Inc	0781-1831
Amoxicillin and Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2210
Amoxicillin and Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2735
Amoxicillin and Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2999
Amoxicillin And Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	DirectRx	72189-281
Amoxicillin and Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-507