Prescription drug · ANDA
Amoxicillin and Clavulanate Potassium NDC 68071-2518
Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL · Powder, For suspension · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-2518-1 | 68071251801 | 100 mL in 1 BOTTLE (68071-2518-1)Marketed from Aug 25, 2021 |
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 — 400 mg/5mLClavulanate potassium — 57 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201090
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-2518_54131e76-5bdd-6fb5-e063-6394a90ad25fSPL ID 54131e76-5bdd-6fb5-e063-6394a90ad25fSPL set ID ca664448-12fb-0c6f-e053-2995a90a262cRxCUI 617430UNII 804826J2HU, Q42OMW3AT8UPC 0368071251814
- 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
N468071251801followed by a unit qualifier and the quantityPackage 68071-2518-01. 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 for oral suspension, USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, USP 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 for oral suspension, USP is a combinatio…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201090
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 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals, Inc. | 68071-3807 |
| Amoxicillin/Clav Pot Oral Susp | Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL | Powder, For suspensionOral | Direct_Rx | 72189-367 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL | Powder, For suspensionOral | HAWAII REPACK, INC. | 85534-0080 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-6694 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-5873 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-5932 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-2227 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-3309 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL | Powder, For suspensionOral | NorthStar Rx LLC | 16714-292 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL | Powder, For suspensionOral | NorthStar Rx LLC | 16714-293 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 71205-462 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8306 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8318 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-533 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-534 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL | Powder, For suspensionOral | Asclemed USA, Inc. | 76420-859 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL | Powder, For suspensionOral | Asclemed USA, Inc. | 76420-864 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-6222 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL | Powder, For suspensionOral | HAWAII REPACK, INC. | 85534-0041 |