Amoxicillin And Clavulanate Potassium NDC 81964-204

NDC codes

FDA NDC Directory

Product NDC (as listed)81964-204Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81964-0204Add 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
81964-204-07	81964020407	75 mL in 1 BOTTLE (81964-204-07)Marketed from Dec 5, 2022
81964-204-10	81964020410	100 mL in 1 BOTTLE (81964-204-10)Marketed from Dec 5, 2022
81964-204-15	81964020415	150 mL in 1 BOTTLE (81964-204-15)Marketed from Dec 5, 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 — 250 mg/5mLClavulanate potassium — 62.5 mg/5mL
Dosage form: For suspension
Route: Oral
Labeler: USAntibiotics, LLC
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 050575
Marketing start: Dec 5, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 81964-204_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

N481964020407 followed by a unit qualifier and the quantity

Package 81964-0204-07. 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 050575

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

FDA NDC Directory listings under NDA 050575
Product	Strength	Form · route	Labeler	Product NDC
Augmentinamoxicillin and clavulanate potassium	Amoxicillin 125 mg/5mL; Clavulanate potassium 31.25 mg/5mL	For suspensionOral	Allegis Holdings, LLC	71297-240
Amoxicillin And Clavulanate Potassium	Amoxicillin 125 mg/5mL; Clavulanate potassium 31.25 mg/5mL	For suspensionOral	USAntibiotics, LLC	81964-212