Prescription drug · NDA AUTHORIZED GENERIC
Amoxicillin And Clavulanate Potassium NDC 68071-3774
Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL · For suspension · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3774-5 | 68071377405 | 125 mL in 1 BOTTLE (68071-3774-5)Marketed from Jan 14, 2025 |
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 — 600 mg/5mLClavulanate potassium — 42.9 mg/5mL
- Dosage form
- For suspension
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 050755
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-3774_2bb03d3b-5d45-bc4a-e063-6394a90a656aSPL ID 2bb03d3b-5d45-bc4a-e063-6394a90a656aSPL set ID 2bb03d3b-5d44-bc4a-e063-6394a90a656aRxCUI 617993UNII 804826J2HU, Q42OMW3AT8UPC 0368071377453
- 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
N468071377405followed by a unit qualifier and the quantityPackage 68071-3774-05. 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 is indicated for the treatment of pediatric patients with Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-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 Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and Clavulanate Potassium…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 050755
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 |
|---|---|---|---|---|
| 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 | USAntibiotics, LLC | 81964-203 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | For suspensionOral | Redpharm Drug | 67296-1921 |