Prescription drug · ANDA
Amoxil (Amoxicillin oral susp) NDC 72189-385
Amoxicillin 400 mg/5mL · Powder, For suspension · Oral · DirectRx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-385-32 | 7218903853272189038532 | 100 mL in 1 BOTTLE (72189-385-32)Marketed from Oct 21, 2022 |
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)
- Amoxil
- Generic name (nonproprietary)
- amoxicillin oral susp
- Active ingredients
- Amoxicillin — 400 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- DirectRxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065325
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 72189-385_2c4cbe6c-c27d-15fe-e063-6294a90ac409SPL ID 2c4cbe6c-c27d-15fe-e063-6294a90ac409SPL set ID ec7dd735-dc92-3d29-e053-2a95a90af549UNII 804826J2HU
- 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
N472189038532followed by a unit qualifier and the quantityPackage 72189-0385-32. 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 for Oral Suspension 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 is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the condit…
Excerpt only. Read the full label for complete information.
About NDC 72189-385
- What is NDC 72189-385?
- 72189-385 is the product NDC for Amoxil (amoxicillin oral susp), Amoxicillin 400 mg/5mL powder, for suspension, listed with the FDA by DirectRx. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amoxil (Amoxicillin Oral Susp).
- What is the active ingredient?
- Amoxicillin.
- Who is the labeler?
- DirectRx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Amoxil?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 065325
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 200 mg/5mL | Powder, For suspensionOral | Hikma Pharmaceuticals USA Inc. | 0143-9886 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | Hikma Pharmaceuticals USA Inc. | 0143-9887 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-0858 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-1086 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-1347 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-1675 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-4796 |
| Amoxicillin | Amoxicillin 200 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-7323 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8730 |
| Amoxicillin | Amoxicillin 200 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8852 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 71205-422 |