NDC codes

FDA NDC Directory
Product NDC (as listed)59651-026Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0026Add 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
59651-026-0159651002601100 mL in 1 BOTTLE (59651-026-01)Marketed from Apr 19, 2019
59651-026-5559651002655150 mL in 1 BOTTLE (59651-026-55)Marketed from Apr 19, 2019
59651-026-755965100267575 mL in 1 BOTTLE (59651-026-75)Marketed from Apr 19, 2019

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 — 250 mg/5mLClavulanate potassium — 62.5 mg/5mL
Dosage form
Powder, For suspension
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209371
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers
Product ID 59651-026_b094fa0e-afc6-46ed-a2ab-105722623e38SPL ID b094fa0e-afc6-46ed-a2ab-105722623e38SPL set ID 3ae0c95f-7ffa-4317-9fea-4d07b86bee72RxCUI 617302, 617322UNII 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

N459651002601 followed by a unit qualifier and the quantity

Package 59651-0026-01. 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 .

Indications (excerpt from the label)

Amoxicillin and clavulanate potassium for oral suspension is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for the treatment of infections caused by designated susceptible (confirmed or suspected) beta-lactamase-producing microorganisms ( 1 ): Lower Respiratory Tract Infections ( 1.1 ) Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets Acute Bacterial Sinusitis ( 1.3 ) Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-026

What is NDC 59651-026?
59651-026 is the product NDC for Amoxicillin and Clavulanate Potassium, Amoxicillin 250 mg/5mL; Clavulanate potassium 62.5 mg/5mL powder, for suspension, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, 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?
Aurobindo Pharma Limited, NDC labeler code 59651. 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?
201 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 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralDevatis, Inc.73043-00773043-0007-20
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralDevatis, Inc.73043-00673043-0006-20

All 202 Amoxicillin and Clavulanate Potassium NDCs

Other NDCs under ANDA 209371

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

FDA NDC Directory listings under ANDA 209371
ProductStrengthForm · routeLabelerProduct NDC
Amoxicillin and Clavulanate PotassiumAmoxicillin 125 mg/5mL; Clavulanate potassium 31.25 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited59651-025

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