Amoxicillin and Clavulanate Potassium NDC 85766-123

NDC codes

FDA NDC Directory

Product NDC (as listed)85766-123Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85766-0123Add 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
85766-123-28	85766012328	28 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (85766-123-28)Marketed from Nov 6, 2025

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: Clavulanate potassium — 62.5 mg/1Amoxicillin — 562.5 mg/1Amoxicillin sodium — 437.5 mg/1
Dosage form: Tablet, Multilayer, Extended release
Route: Oral
Labeler: Sportpharm LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090227
Marketing start: Apr 21, 2010
Listing expires: Dec 31, 2027
Other FDA classes: Penicillins (Chemical structure)Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 85766-123_50322015-adbe-6d1c-e063-6294a90a508fSPL ID 50322015-adbe-6d1c-e063-6294a90a508fSPL set ID cd7d2c0c-bf58-457a-b3d1-bb4c167cd127RxCUI 617995UNII Q42OMW3AT8, 804826J2HU, 544Y3D6MYH
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

N485766012328 followed by a unit qualifier and the quantity

Package 85766-0123-28. 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 Apr 24, 2026.

Indications (excerpt from the label)

Amoxicillin and clavulanate potassium extended-release tablets is indicated for the treatment of infections in adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with: community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected β-lactamase-producing pathogens (i.e., H. influenzae, M. catarrhalis, H. parainfluenzae, K. pneumoniae , or methicillin-susceptible S. aureus ) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs equal to 2 mcg/mL). Limitations of Use Amoxicillin and clavulanate potassium extended-release tablets is not indicated for the treatment of infections due to S. pneu…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090227

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

FDA NDC Directory listings under ANDA 090227
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin and Clavulanate Potassium	Amoxicillin 562.5 mg/1 + 2 more ingredients	Tablet, Multilayer, Extended releaseOral	Sandoz Inc	0781-1943