Prescription drug · ANDA
Amoxicillin NDC 72189-285
Amoxicillin 400 mg/5mL · Powder, For suspension · Oral · DirectRx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-285-32 | 72189028532 | 100 mL in 1 BOTTLE (72189-285-32)Marketed from Oct 21, 2021 |
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
- DirectRx
- 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 72189-285_2c2940b3-68cf-ce12-e063-6394a90aef2cSPL ID 2c2940b3-68cf-ce12-e063-6394a90aef2cSPL set ID cedde8f5-aadd-53de-e053-2995a90aab16RxCUI 308189UNII 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
N472189028532followed by a unit qualifier and the quantityPackage 72189-0285-32. 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)
1.1 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. 1.2 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. 1.3 Infections of the Skin and Skin Structure Amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (ONLY …
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 | 63187-262 |
| 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 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 |