What is NDC 0781-6104?

0781-6104 is the product NDC for Amoxicillin and Clavulanate Potassium, Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL powder, for suspension, listed with the FDA by Sandoz Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Amoxicillin, Clavulanate potassium.

Sandoz Inc, NDC labeler code 0781. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amoxicillin and Clavulanate Potassium NDC 0781-6104

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-6104Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-6104Add 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
0781-6104-46	00781610446	100 mL in 1 BOTTLE (0781-6104-46)Marketed from Jun 5, 2002
0781-6104-52	00781610452	50 mL in 1 BOTTLE (0781-6104-52)Marketed from Dec 18, 2023
0781-6104-57	00781610457	75 mL in 1 BOTTLE (0781-6104-57)Marketed from Dec 18, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 400 mg/5mLClavulanate potassium — 57 mg/5mL
Dosage form: Powder, For suspension
Route: Oral
Labeler: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065066
Marketing start: Jun 5, 2002
Listing expires: Dec 31, 2026
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 0781-6104_6a6233c9-2bba-4d8c-9bfa-e5c5055cf91fSPL ID 6a6233c9-2bba-4d8c-9bfa-e5c5055cf91fSPL set ID 7cba82f0-9886-46e9-8dbd-43a448aade29RxCUI 562251, 562508, 617296, 617423, 617430UNII 804826J2HU, Q42OMW3AT8UPC 0307816102462, 0307811831206, 0307811874319, 0307811852201
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

N400781610446 followed by a unit qualifier and the quantity

Package 00781-6104-46. 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 May 1, 2025.

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 species…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-6104

What is NDC 0781-6104?: 0781-6104 is the product NDC for Amoxicillin and Clavulanate Potassium, Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL powder, for suspension, listed with the FDA by Sandoz Inc. 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?: Sandoz Inc, NDC labeler code 0781. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, CoatedOral	REMEDYREPACK INC.	70518-4758	70518-4758-00
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL	Powder, For suspensionOral	Preferred Pharmaceuticals Inc.	68788-4179	68788-4179-01
Amoxicillin And Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0366	67046-0366-03
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0955	67046-0955-03
Amoxicillin and Clavulanate Potassium	Amoxicillin 562.5 mg/1 + 2 more ingredients	Tablet, Film coated, Extended releaseOral	USAntibiotics, LLC	81964-220	81964-0220-2881964-0220-40
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4424	70518-4424-00
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8836	68788-8836-02
Amoxicillin and Clavulanate Potassium	Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL	SuspensionOral	Preferred Pharmaceuticals Inc.	68788-8770	68788-8770-0168788-8770-07
Amoxicillin and Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Devatis, Inc.	73043-007	73043-0007-20
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Devatis, Inc.	73043-006	73043-0006-20

All 202 Amoxicillin and Clavulanate Potassium NDCs

Other NDCs under ANDA 065066

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

FDA NDC Directory listings under ANDA 065066
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin and Clavulanate Potassium	Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL	Powder, For suspensionOral	Sandoz Inc	0781-6102