Amoxicillin and Clavulanate Potassium NDC 0143-9853

NDC codes

FDA NDC Directory

Product NDC (as listed)0143-9853Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00143-9853Add 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
0143-9853-16	00143985316	125 mL in 1 BOTTLE (0143-9853-16)Marketed from Aug 3, 2009
0143-9853-24	00143985324	200 mL in 1 BOTTLE (0143-9853-24)Marketed from Aug 3, 2009
0143-9853-75	00143985375	75 mL in 1 BOTTLE (0143-9853-75)Marketed from Aug 3, 2009

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 — 600 mg/5mLClavulanate potassium — 42.9 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065373
Marketing start: Aug 3, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 0143-9853_45f95702-3be8-47a5-8de8-3b17457aa04aSPL ID 45f95702-3be8-47a5-8de8-3b17457aa04aSPL set ID 6339bcdb-060f-4558-9f42-6bf7f935e138RxCUI 617993UNII 804826J2HU, Q42OMW3AT8UPC 0301439853244, 0301439853169, 0301439853756
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

N400143985316 followed by a unit qualifier and the quantity

Package 00143-9853-16. 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 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with: Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors: -Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology ( 12.4 )] . Limitations of Use …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065373

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

FDA NDC Directory listings under ANDA 065373
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin and Clavulanate Potassium	Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL	SuspensionOral	Preferred Pharmaceuticals Inc.	68788-8299
Amoxicillin and Clavulanate Potassium	Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL	SuspensionOral	Preferred Pharmaceuticals Inc.	68788-8770