Prescription drug · ANDA
Amoxicillin NDC 0143-9887
Amoxicillin 400 mg/5mL · Powder, For suspension · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9887-01 | 00143988701 | 100 mL in 1 BOTTLE (0143-9887-01)Marketed from Jun 19, 2006 | |
| 0143-9887-50 | 00143988750 | 50 mL in 1 BOTTLE (0143-9887-50)Marketed from Jun 19, 2006 | |
| 0143-9887-75 | 00143988775 | 75 mL in 1 BOTTLE (0143-9887-75)Marketed from Jun 19, 2006 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- 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 0143-9887_606474e1-adba-4ffa-83d5-6565fc12c892SPL ID 606474e1-adba-4ffa-83d5-6565fc12c892SPL set ID d46f1091-33dc-4f8f-9c34-75dcfedb4b4cRxCUI 308189, 313850UNII 804826J2HUUPC 0301439887508, 0301439886501
- 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
N400143988701followed by a unit qualifier and the quantityPackage 00143-9887-01. 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, USP 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, USP 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, USP is ind…
Excerpt only. Read the full label for complete information.
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 400 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8730 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-1675 |
| Amoxilamoxicillin oral susp | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | DirectRx | 72189-385 |
| Amoxicillin | Amoxicillin 200 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-7323 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-0858 |
| 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 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-4796 |
| 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 200 mg/5mL | Powder, For suspensionOral | Hikma Pharmaceuticals USA Inc. | 0143-9886 |