Amoxicillin And Clavulanate Potassium NDC 68788-8307

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8307Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8307Add 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
68788-8307-2	68788830702	20 TABLET, COATED in 1 BOTTLE (68788-8307-2)Marketed from Dec 20, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Preferred Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 050720
Marketing start: Dec 20, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 68788-8307_23c2896b-d08f-4948-ac77-e15df706eeacSPL ID 23c2896b-d08f-4948-ac77-e15df706eeacSPL set ID 1b8a6312-ae47-45fb-ba5e-eedbc176afa0RxCUI 562508UNII 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

N468788830702 followed by a unit qualifier and the quantity

Package 68788-8307-02. 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 Mar 3, 2026.

Indications (excerpt from the label)

Amoxicillin and Clavulanate Potassium is 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 spec…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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	USAntibiotics, LLC	81964-221
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