Prescription drug · ANDA
Amoxicillin NDC 63187-029
Amoxicillin 250 mg/5mL · Powder, For suspension · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-029-15 | 63187002915 | 150 mL in 1 BOTTLE (63187-029-15)Marketed from May 1, 2014 |
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 — 250 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 065322
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 63187-029_e61645ee-b492-46b5-bb37-8df0e39e20d8SPL ID e61645ee-b492-46b5-bb37-8df0e39e20d8SPL set ID 9cac2bf2-fb48-4e83-b953-61c4d55f7e19RxCUI 239191UNII 804826J2HUUPC 0363187029159
- 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
N463187002915followed by a unit qualifier and the quantityPackage 63187-0029-15. 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 and other antibacterial drugs, Amoxicillin Powder 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 Powder for Oral Suspension, USP is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designate…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065322
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 250 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 66267-993 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 63187-295 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals Inc. | 68071-3678 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-4024 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-2364 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-2251 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-0404 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | Hikma Pharmaceuticals USA Inc. | 0143-9888 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-0407 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-0405 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-0406 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-1761 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-0411 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-1760 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8759 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | Hikma Pharmaceuticals USA Inc. | 0143-9889 |