Prescription drug · NDA AUTHORIZED GENERIC
Amoxicillin and Clavulanate Potassium NDC 81964-220
Amoxicillin 562.5 mg/1 + 2 more ingredients · Tablet, Film coated, Extended release · Oral · USAntibiotics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81964-220-28 | 8196402202881964022028 | 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-28)Marketed from Dec 15, 2025 | |
| 81964-220-40 | 8196402204081964022040 | 40 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-40)Marketed from Dec 15, 2025 |
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 — 562.5 mg/1Clavulanate potassium — 62.5 mg/1Amoxicillin sodium — 437.5 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- USAntibiotics, LLCNDC labeler code 81964
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 050785
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 81964-220_52498ef2-86fc-72b6-e063-6294a90a4232SPL ID 52498ef2-86fc-72b6-e063-6294a90a4232SPL set ID 45c60b69-1b65-01ed-e063-6294a90a57beRxCUI 617995UNII 804826J2HU, Q42OMW3AT8, 544Y3D6MYHUPC 0381964220285, 0381964220407
- 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
N481964022028followed by a unit qualifier and the quantityPackage 81964-0220-28. 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 .
Indications (excerpt from the label)
Amoxicillin and Clavulanate Potassium Extended Release Tablets is indicated for the treatment of infections in adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with: community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected beta-lactamase-producing pathogens (i.e., H. influenzae , M. catarrhalis , H. parainfluenzae , K. pneumoniae , or methicillin-susceptible S. aureus ) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs equal to 2 mcg/mL). Limitations of Use Amoxicillin and Clavulanate Potassium Extended Release Tablets is not indicated for the treatment of infections due to S…
Excerpt only. Read the full label for complete information.
About NDC 81964-220
- What is NDC 81964-220?
- 81964-220 is the product NDC for Amoxicillin and Clavulanate Potassium, Amoxicillin 562.5 mg/1 + 2 more ingredients tablet, film coated, extended release, listed with the FDA by USAntibiotics, LLC. It has 2 package NDCs, 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, Amoxicillin sodium.
- Who is the labeler?
- USAntibiotics, LLC, NDC labeler code 81964. 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.
Related NDCs: other Amoxicillin and Clavulanate Potassium products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0366 | 67046-0366-03 |
| 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 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 |