Prescription drug · ANDA

Amoxicillin and Clavulanate Potassium NDC 65862-502

Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)65862-502Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0502Add 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
65862-502-0565862050205500 TABLET, FILM COATED in 1 BOTTLE (65862-502-05)Marketed from Jan 20, 2012
65862-502-206586205022020 TABLET, FILM COATED in 1 BOTTLE (65862-502-20)Marketed from Jan 20, 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
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 65862-502_1fbab977-8fa7-47ba-9b7d-d5478e261d0dSPL ID 1fbab977-8fa7-47ba-9b7d-d5478e261d0d
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

N465862050205 followed by a unit qualifier and the quantity

Package 65862-0502-05. 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

The FDA listing for this product does not reference a label (SPL) set.

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 coatedOralPD-Rx Pharmaceuticals, Inc.72789-533
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 coatedOralNuCare Pharmaceuticals,Inc.68071-3947
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 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 coatedOralNorthStar Rx LLC16714-296
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 LLC85766-022
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 coatedOralA-S Medication Solutions50090-6997
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

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Amoxicillin and Clavulanate Potassium NDC 65862-502 | Med-Code