Prescription drug · NDA
Augmentin NDC 71297-240
amoxicillin and clavulanate potassium · Amoxicillin 125 mg/5mL; Clavulanate potassium 31.25 mg/5mL · For suspension · Oral · Allegis Holdings, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71297-240-34 | 71297024034 | 75 mL in 1 BOTTLE (71297-240-34)Marketed from Feb 20, 2024 | |
| 71297-240-35 | 71297024035 | 100 mL in 1 BOTTLE (71297-240-35)Marketed from Sep 1, 2023 | |
| 71297-240-36 | 71297024036 | 150 mL in 1 BOTTLE (71297-240-36)Marketed from Sep 1, 2023 |
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)
- Augmentin
- Generic name (nonproprietary)
- amoxicillin and clavulanate potassium
- Active ingredients
- Amoxicillin — 125 mg/5mLClavulanate potassium — 31.25 mg/5mL
- Dosage form
- For suspension
- Route
- Oral
- Labeler
- Allegis Holdings, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050575
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 71297-240_18975386-c292-a0cb-e063-6294a90aed18SPL ID 18975386-c292-a0cb-e063-6294a90aed18SPL set ID 04a31a42-d79e-bbb4-e063-6394a90a63eeRxCUI 617302, 617333UNII 804826J2HU, Q42OMW3AT8UPC 0371297240364, 0371297240340
- 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
N471297024034followed by a unit qualifier and the quantityPackage 71297-0240-34. 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)
AUGMENTIN is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: Lower Respiratory Tract Infections - caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . Acute Bacterial Otitis Media - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . Sinusitis - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . Skin and Skin Structure Infections - caused by beta‑lactamase–producing isolates of Staphylococcus aureus , Escherichia coli , and Klebsiella species. Urinary Tract Infections - caus…
Excerpt only. Read the full label for complete information.
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 250 mg/5mL; Clavulanate potassium 62.5 mg/5mL | For suspensionOral | USAntibiotics, LLC | 81964-204 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 125 mg/5mL; Clavulanate potassium 31.25 mg/5mL | For suspensionOral | USAntibiotics, LLC | 81964-212 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.