Prescription drug · ANDA
Amoxicillin NDC 63187-262
Amoxicillin 400 mg/5mL · Powder, For suspension · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-262-00 | 63187026200 | 100 mL in 1 BOTTLE (63187-262-00)Marketed from Feb 2, 2015 | |
| 63187-262-50 | 63187026250 | 50 mL in 1 BOTTLE (63187-262-50)Marketed from Jan 11, 2024 |
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
- Generic name (nonproprietary)
- amoxicillin
- Active ingredients
- Amoxicillin — 400 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 065334
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 63187-262_e6603270-d47e-47fc-bea9-0c1cea9f70aaSPL ID e6603270-d47e-47fc-bea9-0c1cea9f70aaSPL set ID fcdaba34-373f-4d4e-8203-76f02e3bb00aRxCUI 308189UNII 804826J2HUUPC 0363187262006
- Pharmacologic class
- Penicillin-class Antibacterial
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
N463187026200followed by a unit qualifier and the quantityPackage 63187-0262-00. 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)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin for oral suspension, USP and other antibacterial drugs, amoxicillin for oral suspension, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin for oral suspension, USP is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of th…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065334
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 | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-6355 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-5109 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 63187-335 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | REMEDYREPACK INC. | 70518-4522 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | DIRECT RX | 61919-401 |
| Amoxicillin | Amoxicillin 200 mg/5mL | Powder, For suspensionOral | Rising Pharma Holdings, Inc. | 57237-032 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | Rising Pharma Holdings, Inc. | 57237-033 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8325 |
| Amoxicillin | Amoxicillin 200 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8324 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | DirectRx | 72189-285 |
| Amoxicillin | Amoxicillin 200 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 71205-775 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-071 |
| Amoxicillin | Amoxicillin 200 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-070 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-6323 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-6680 |