Prescription drug · ANDA
Amoxicillin and Clavulanate Potassium NDC 82804-017
Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL · Powder, For suspension · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-017-12 | 82804001712 | 125 mL in 1 BOTTLE (82804-017-12)Marketed from Oct 5, 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)
- Amoxicillin and Clavulanate Potassium
- Generic name (nonproprietary)
- amoxicillin and clavulanate potassium
- Active ingredients
- Amoxicillin — 600 mg/5mLClavulanate potassium — 42.9 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201091
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 82804-017_e05caabb-b95c-4e54-890e-bbc371a20fc3SPL ID e05caabb-b95c-4e54-890e-bbc371a20fc3SPL set ID e05caabb-b95c-4e54-890e-bbc371a20fc3RxCUI 617993UNII 804826J2HU, Q42OMW3AT8UPC 0382804017126
- 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
N482804001712followed by a unit qualifier and the quantityPackage 82804-0017-12. 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 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) day care attendance [see Microbiology (12.4)] . Limitations of Use Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin an…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201091
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 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-5144 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-1857 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 71205-036 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals, Inc. | 68788-0483 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-5207 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-2355 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-2219 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | Powder, For suspensionOral | Redpharm Drug | 67296-2234 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | Powder, For suspensionOral | NorthStar Rx LLC | 16714-294 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-535 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-2852 |