Prescription drug · ANDA
Amoxicillin NDC 82804-134
Amoxicillin 250 mg/5mL · Powder, For suspension · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-134-15 | 82804013415 | 150 mL in 1 BOTTLE (82804-134-15)Marketed from Aug 15, 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 — 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 204030
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 82804-134_c8e5ad7d-09b7-41d9-8cb0-467b3e8df74fSPL ID c8e5ad7d-09b7-41d9-8cb0-467b3e8df74fSPL set ID c8e5ad7d-09b7-41d9-8cb0-467b3e8df74fRxCUI 239191UNII 804826J2HUUPC 0382804134151
- 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
N482804013415followed by a unit qualifier and the quantityPackage 82804-0134-15. 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)
Adults and Pediatric Patients • Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . • Infections of the Genitourinary Tract: Amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis . • Infections of the Skin and Skin Structure: Amoxicillin for oral suspension is indicated in…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204030
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 | A-S Medication Solutions | 50090-6351 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-6349 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-707 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-706 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-6791 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-6469 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-2397 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-6319 |