NDC codes

FDA NDC Directory
Product NDC (as listed)85766-022Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85766-0022Add 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 NDC11-digit (billing)PackageCopy
85766-022-20857660022208576600222020 TABLET, FILM COATED in 1 BOTTLE (85766-022-20)Marketed from Aug 13, 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

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
Sportpharm LLCNDC labeler code 85766
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091569
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers
Product ID 85766-022_4a022ff2-b0e8-9063-e063-6294a90a8fbeSPL ID 4a022ff2-b0e8-9063-e063-6294a90a8fbeSPL set ID 94b7c1bb-c024-4dc6-86d4-18a17a3eafcbRxCUI 562508, 617296UNII 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

N485766002220 followed by a unit qualifier and the quantity

Package 85766-0022-20. 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 .

Indications (excerpt from the label)

Amoxicillin and clavulanate potassium tablets 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 Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella speci…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85766-022

What is NDC 85766-022?
85766-022 is the product NDC for Amoxicillin and Clavulanate Potassium, Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 tablet, film coated, listed with the FDA by Sportpharm LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Amoxicillin and Clavulanate Potassium.
What is the active ingredient?
Amoxicillin, Clavulanate potassium.
Who is the labeler?
Sportpharm LLC, NDC labeler code 85766. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amoxicillin and Clavulanate Potassium?
200 other product NDCs are listed under this name. See all Amoxicillin and Clavulanate Potassium NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Amoxicillin and Clavulanate Potassium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-475870518-4758-00
Amoxicillin and Clavulanate PotassiumAmoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-417968788-4179-01
Amoxicillin And Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralCoupler LLC67046-036667046-0366-03
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralCoupler LLC67046-095567046-0955-03
Amoxicillin and Clavulanate PotassiumAmoxicillin 562.5 mg/1 + 2 more ingredientsTablet, Film coated, Extended releaseOralUSAntibiotics, LLC81964-22081964-0220-2881964-0220-40
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-442470518-4424-00
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-883668788-8836-02
Amoxicillin and Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLSuspensionOralPreferred Pharmaceuticals Inc.68788-877068788-8770-0168788-8770-07
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralDevatis, Inc.73043-00673043-0006-20
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralDevatis, Inc.73043-00773043-0007-20

All 201 Amoxicillin and Clavulanate Potassium NDCs

Other NDCs under ANDA 091569

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

FDA NDC Directory listings under ANDA 091569
ProductStrengthForm · routeLabelerProduct NDC
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-502
Amoxicillin and Clavulanate PotassiumAmoxicillin 250 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-501
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8317
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralSportpharm LLC85766-079
Amoxicillin and Clavulanate PotassiumAmoxicillin 250 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralSportpharm LLC85766-080
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6997
Amoxicillin and Clavulanate PotassiumAmoxicillin 250 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-781
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-792
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2896
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2933
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5065
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-0820
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-296
Amoxicillin and Clavulanate PotassiumAmoxicillin 250 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-295
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3947
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-533

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