Amoxicillin and Clavulanate Potassium NDC 71205-712

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-712Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0712Add 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
71205-712-10	71205071210	10 TABLET, FILM COATED in 1 BOTTLE (71205-712-10)Marketed from Nov 15, 2022
71205-712-14	71205071214	14 TABLET, FILM COATED in 1 BOTTLE (71205-712-14)Marketed from Nov 15, 2022
71205-712-20	71205071220	20 TABLET, FILM COATED in 1 BOTTLE (71205-712-20)Marketed from Nov 15, 2022
71205-712-21	71205071221	21 TABLET, FILM COATED in 1 BOTTLE (71205-712-21)Marketed from Nov 15, 2022
71205-712-28	71205071228	28 TABLET, FILM COATED in 1 BOTTLE (71205-712-28)Marketed from Nov 15, 2022
71205-712-30	71205071230	30 TABLET, FILM COATED in 1 BOTTLE (71205-712-30)Marketed from Nov 15, 2022
71205-712-60	71205071260	60 TABLET, FILM COATED in 1 BOTTLE (71205-712-60)Marketed from Nov 15, 2022
71205-712-90	71205071290	90 TABLET, FILM COATED in 1 BOTTLE (71205-712-90)Marketed from Nov 15, 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, Film coated
Route: Oral
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065063
Marketing start: May 1, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 71205-712_a0d22635-0e11-448d-b151-6f6168c65723SPL ID a0d22635-0e11-448d-b151-6f6168c65723SPL set ID a0d22635-0e11-448d-b151-6f6168c65723RxCUI 562508UNII 804826J2HU, Q42OMW3AT8UPC 0371205712204
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

N471205071210 followed by a unit qualifier and the quantity

Package 71205-0712-10. 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 Nov 1, 2022.

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)

Other NDCs under ANDA 065063

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

FDA NDC Directory listings under ANDA 065063
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-2982
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Sandoz Inc	0781-1852
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3866
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2211
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-651
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-488
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-501
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3624
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3822
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3842