Amoxicillin and Clavulanate Potassium NDC 0143-9982

NDC codes

FDA NDC Directory

Product NDC (as listed)0143-9982Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00143-9982Add 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
0143-9982-01	00143998201	100 mL in 1 BOTTLE (0143-9982-01)Marketed from Dec 1, 2007
0143-9982-50	00143998250	50 mL in 1 BOTTLE (0143-9982-50)Marketed from Dec 1, 2007
0143-9982-75	00143998275	75 mL in 1 BOTTLE (0143-9982-75)Marketed from Dec 1, 2007

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/5mLClavulanic acid — 57 mg/5mL
Dosage form: Powder, For suspension
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065191
Marketing start: Dec 1, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 0143-9982_29e9e32b-e9a3-48b5-a1c7-14b3bbe447e5SPL ID 29e9e32b-e9a3-48b5-a1c7-14b3bbe447e5SPL set ID 240bcdcb-31d9-40a0-87e1-bd16264a2e20RxCUI 617423, 617430UNII 804826J2HU, 23521W1S24UPC 0301439981015, 0301439982012
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

N400143998201 followed by a unit qualifier and the quantity

Package 00143-9982-01. 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 Feb 28, 2025.

Indications (excerpt from the label)

Amoxicillin and Clavulanate Potassium for Oral Suspension 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065191

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

FDA NDC Directory listings under ANDA 065191
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL	Powder, For suspensionOral	NuCare Pharmaceuticals,Inc.	68071-1619
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL	Powder, For suspensionOral	Preferred Pharmaceuticals Inc.	68788-4179
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-0928
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL	Powder, For suspensionOral	Proficient Rx LP	63187-826
Amoxicillin and Clavulanate Potassium	Amoxicillin 200 mg/5mL; Clavulanic acid 28.5 mg/5mL	Powder, For suspensionOral	Hikma Pharmaceuticals USA Inc.	0143-9981