Prescription drug · ANDA
Amoxicillin and Clavulanate Potassium NDC 0093-2279
Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL · Powder, For suspension · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-2279-73 | 00093227973 | 100 mL in 1 BOTTLE (0093-2279-73)Marketed from Jan 13, 2005 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 400 mg/5mLClavulanate potassium — 57 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065089
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 0093-2279_aaf9ce2f-41c3-489c-b5c1-f4f553d84854SPL ID aaf9ce2f-41c3-489c-b5c1-f4f553d84854SPL set ID 963e7bea-ff5d-420a-9cb2-e4aefb534b33RxCUI 562508, 617296, 617423, 617430UNII 804826J2HU, Q42OMW3AT8UPC 0300932274341, 0300932275348
- 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
N400093227973followed by a unit qualifier and the quantityPackage 00093-2279-73. 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 tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065089
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 400 mg/5mL; Clavulanate potassium 57 mg/5mL | Powder, For suspensionOral | Chartwell RX, LLC | 62135-094 |
| amoxicillin and clavulanate potassium | Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL | Powder, For suspensionOral | Chartwell RX, LLC | 62135-093 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 63187-770 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL | Powder, For suspensionOral | Teva Pharmaceuticals USA, Inc. | 0093-2277 |