Prescription drug · ANDA
Amoxicillin and Clavulanate Potassium NDC 50090-5932
Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL · Powder, For suspension · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5932-0 | 50090593200 | 100 mL in 1 BOTTLE (50090-5932-0)Marketed from Mar 4, 2022 |
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 — 200 mg/5mLClavulanate potassium — 28.5 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- A-S Medication Solutions
- 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 50090-5932_1d0f8bb5-e3dd-4529-90bb-26ec8b334c22SPL ID 1d0f8bb5-e3dd-4529-90bb-26ec8b334c22SPL set ID 77126eee-9534-4e80-9d11-ec78ec66c826RxCUI 617423UNII 804826J2HU, Q42OMW3AT8
- 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
N450090593200followed by a unit qualifier and the quantityPackage 50090-5932-00. 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 for oral suspension 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 Kle…
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 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 400 mg/5mL; Clavulanate potassium 57 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-2518 |
| 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 |