Amoxicillin And Clavulanate Potassium NDC 81964-203

NDC codes

FDA NDC Directory

Product NDC (as listed)81964-203Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81964-0203Add 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
81964-203-51	81964020351	75 mL in 1 BOTTLE (81964-203-51)Marketed from Sep 19, 2022
81964-203-54	81964020354	200 mL in 1 BOTTLE (81964-203-54)Marketed from Sep 19, 2022
81964-203-69	81964020369	125 mL in 1 BOTTLE (81964-203-69)Marketed from Sep 19, 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 — 600 mg/5mLClavulanate potassium — 42.9 mg/5mL
Dosage form: For suspension
Route: Oral
Labeler: USAntibiotics, LLC
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 050755
Marketing start: Sep 19, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 81964-203_52497cef-6663-3e6f-e063-6394a90a35eeSPL ID 52497cef-6663-3e6f-e063-6394a90a35eeSPL set ID 7d4dfd6f-bd1a-4acc-8506-07fca08f8a38RxCUI 617993UNII 804826J2HU, Q42OMW3AT8UPC 0381964203691, 0381964203547
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

N481964020351 followed by a unit qualifier and the quantity

Package 81964-0203-51. 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 Jul 7, 2026.

Indications (excerpt from the label)

Amoxicillin and Clavulanate Potassium (600 mg/42.9 mg) for Oral Suspension 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) daycare attendance [see Microbiology ( 12.4 )] Limitations of Use Amoxicill…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 050755

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

FDA NDC Directory listings under NDA 050755
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin And Clavulanate Potassium	Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL	For suspensionOral	NuCare Pharmaceuticals, Inc.	68071-3774
Augmentin ES-600amoxicillin and clavulanate potassium	Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL	For suspensionOral	USAntibiotics, LLC	81964-003
Amoxicillin And Clavulanate Potassium	Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL	For suspensionOral	Redpharm Drug	67296-1921