Prescription drug · ANDA
Amoxicillin And Clavulanate Potassium NDC 68071-4284
Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4284-3 | 68071428403 | 3 TABLET, FILM COATED in 1 BOTTLE (68071-4284-3)Marketed from Feb 15, 2018 | |
| 68071-4284-4 | 68071428404 | 4 TABLET, FILM COATED in 1 BOTTLE (68071-4284-4)Marketed from Feb 15, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 500 mg/1Clavulanate potassium — 125 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205707
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-4284_1a3dcabb-3683-ad32-e063-6394a90a6731SPL ID 1a3dcabb-3683-ad32-e063-6394a90a6731SPL set ID 6542fa18-6219-602f-e053-2991aa0a54d0RxCUI 617296UNII 804826J2HU, Q42OMW3AT8UPC 0368071428438
- 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
N468071428403followed by a unit qualifier and the quantityPackage 68071-4284-03. 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)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets USP, and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets USP is a combination penicillin-class antibacterial and beta-lactamas…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205707
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 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0366 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 250 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2896 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7998 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-014 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Medsource Pharmaceuticals | 45865-230 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-161 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 250 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-160 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2625 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2824 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4275 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4300 |
| Amoxicillin/Clav Pot | Clavulanate potassium 125 mg/1; Amoxicillin 500 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-638 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2433 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 250 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2435 |