Amoxicillin and Clavulanate Potassium NDC 55289-845

NDC codes

FDA NDC Directory

Product NDC (as listed)55289-845Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55289-0845Add 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
55289-845-06	55289084506	6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-06)Marketed from Dec 6, 2012
55289-845-20	55289084520	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-20)Marketed from Dec 6, 2012
55289-845-21	55289084521	21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-21)Marketed from Dec 6, 2012
55289-845-28	55289084528	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-28)Marketed from Dec 6, 2012
55289-845-30	55289084530	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-30)Marketed from Dec 6, 2012

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: PD-Rx Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065101
Marketing start: Oct 31, 2002
Listing expires: Dec 31, 2026
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 55289-845_419b7d75-b6cc-e646-e063-6294a90a8d2eSPL ID 419b7d75-b6cc-e646-e063-6294a90a8d2eSPL set ID cc445a39-d84c-4b76-9fb8-ae302e7cd96bRxCUI 617296UNII 804826J2HU, Q42OMW3AT8UPC 0355289845201
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

N455289084506 followed by a unit qualifier and the quantity

Package 55289-0845-06. 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 Oct 20, 2025.

Indications (excerpt from the label)

Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: Lower Respiratory Tract Infections – caused by beta–lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . Acute Bacterial Otitis Media – caused by beta–lactamase–producing isolates of H. influenzae and M. catarrhalis . Sinusitis – caused by beta–lactamase–producing isolates of H. influenzae and M. catarrhalis . Skin and Skin Structure …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065101

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

FDA NDC Directory listings under ANDA 065101
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	63187-327
amoxicillin and clavulanate potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	TabletOral	Chartwell RX, LLC	62135-091
Amoxicillin and Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-2274
Amoxicillin and Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-418
Amoxicillin and Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-032
Amoxicillin and Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-608