What is NDC 67046-0366?

67046-0366 is the product NDC for Amoxicillin And Clavulanate Potassium, Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Amoxicillin, Clavulanate potassium.

Coupler LLC, NDC labeler code 67046. 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?

200 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 67046-0366

NDC codes

FDA NDC Directory

Product NDC (as listed)67046-0366Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67046-0366Add 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
67046-0366-3	6704603660367046036603	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0366-3)Marketed from May 7, 2026

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 — 500 mg/1Clavulanate potassium — 125 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Coupler LLCNDC labeler code 67046
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205707
Marketing start: May 7, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 67046-0366_513b5796-97cd-f095-e063-6394a90a79aeSPL ID 513b5796-97cd-f095-e063-6394a90a79aeSPL set ID 513b6211-c73b-7e66-e063-6394a90a2aa1RxCUI 617296UNII 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

N467046036603 followed by a unit qualifier and the quantity

Package 67046-0366-03. 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 7, 2026.

Indications (excerpt from the label)

Amoxicillin and clavulanate potassium tablets are 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 Klebsiel…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-0366

What is NDC 67046-0366?: 67046-0366 is the product NDC for Amoxicillin And Clavulanate Potassium, Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. It has 1 package NDC, 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?: Coupler LLC, NDC labeler code 67046. 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?: 200 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 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 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Devatis, Inc.	73043-006	73043-0006-20
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 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL	Powder, For suspensionOral	Devatis Inc.	73043-008	73043-0008-0173043-0008-0273043-0008-03

All 201 Amoxicillin And Clavulanate Potassium NDCs

Other NDCs under ANDA 205707

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

FDA NDC Directory listings under ANDA 205707
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin And Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-2625
Amoxicillin and Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Medsource Pharmaceuticals	45865-230
Amoxicillin And Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4275
Amoxicillin And Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4284
Amoxicillin And Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4300
Amoxicillin And Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7998
Amoxicillin And Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2824
Amoxicillin And Clavulanate Potassium	Amoxicillin 250 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Micro Labs Limited	42571-160
Amoxicillin And Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Micro Labs Limited	42571-161
Amoxicillin And Clavulanate Potassium	Amoxicillin 250 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2435
Amoxicillin And Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-014
Amoxicillin And Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2433
Amoxicillin/Clav Pot	Clavulanate potassium 125 mg/1; Amoxicillin 500 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-638
Amoxicillin And Clavulanate Potassium	Amoxicillin 250 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2896