Prescription drug · NDA AUTHORIZED GENERIC
Amoxicillin And Clavulanate Potassium NDC 81964-204
Amoxicillin 250 mg/5mL; Clavulanate potassium 62.5 mg/5mL · For suspension · Oral · USAntibiotics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81964-204-07 | 8196402040781964020407 | 75 mL in 1 BOTTLE (81964-204-07)Marketed from Dec 5, 2022 | |
| 81964-204-10 | 8196402041081964020410 | 100 mL in 1 BOTTLE (81964-204-10)Marketed from Dec 5, 2022 | |
| 81964-204-15 | 8196402041581964020415 | 150 mL in 1 BOTTLE (81964-204-15)Marketed from Dec 5, 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 — 250 mg/5mLClavulanate potassium — 62.5 mg/5mL
- Dosage form
- For suspension
- Route
- Oral
- Labeler
- USAntibiotics, LLCNDC labeler code 81964
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 050575
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 81964-204_5bba212f-9bf8-29b5-e063-6394a90a8cd2SPL ID 5bba212f-9bf8-29b5-e063-6394a90a8cd2
- 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
N481964020407followed by a unit qualifier and the quantityPackage 81964-0204-07. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 81964-204
- What is NDC 81964-204?
- 81964-204 is the product NDC for Amoxicillin And Clavulanate Potassium, Amoxicillin 250 mg/5mL; Clavulanate potassium 62.5 mg/5mL for suspension, listed with the FDA by USAntibiotics, LLC. It has 3 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.
- 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 562.5 mg/1 + 2 more ingredients | Tablet, Film coated, Extended releaseOral | USAntibiotics, LLC | 81964-220 | 81964-0220-2881964-0220-40 |
| 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 |
Other NDCs under NDA 050575
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Amoxicillin And Clavulanate Potassium | Amoxicillin 125 mg/5mL; Clavulanate potassium 31.25 mg/5mL | For suspensionOral | USAntibiotics, LLC | 81964-212 |
| Augmentinamoxicillin and clavulanate potassium | Amoxicillin 125 mg/5mL; Clavulanate potassium 31.25 mg/5mL | For suspensionOral | Allegis Holdings, LLC | 71297-240 |