Amoxicillin And Clavulanate Potassium NDC 81964-221

NDC codes

FDA NDC Directory

Product NDC (as listed)81964-221Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81964-0221Add 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
81964-221-01	81964022101	100 TABLET, COATED in 1 BOTTLE (81964-221-01)Marketed from May 1, 2024
81964-221-14	81964022114	20 TABLET, COATED in 1 BOTTLE (81964-221-14)Marketed from Nov 21, 2022

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 — 875 mg/1Clavulanate potassium — 125 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: USAntibiotics, LLC
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 050720
Marketing start: Nov 21, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 81964-221_5bba212f-9bf8-29b5-e063-6394a90a8cd2SPL ID 5bba212f-9bf8-29b5-e063-6394a90a8cd2
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

N481964022101 followed by a unit qualifier and the quantity

Package 81964-0221-01. 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

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

Other NDCs under NDA 050720

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

FDA NDC Directory listings under NDA 050720
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, CoatedOral	Preferred Pharmaceuticals Inc.	68788-8307
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, CoatedOral	Proficient Rx LP	82804-060
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, CoatedOral	A-S Medication Solutions	50090-6324