Prescription drug · ANDA
Amoxicillin NDC 68071-5109
Amoxicillin 400 mg/5mL · Powder, For suspension · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-5109-1 | 68071510901 | 100 mL in 1 BOTTLE (68071-5109-1)Marketed from Nov 18, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- NuCare Pharmaceuticals,Inc.
- 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 68071-5109_1b46d42b-ffdd-5da2-e063-6394a90afe28SPL ID 1b46d42b-ffdd-5da2-e063-6394a90afe28SPL set ID 97a657a3-8238-f5f1-e053-2a95a90a7a7aRxCUI 308189UNII 804826J2HUUPC 0368071510911
- 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
N468071510901followed by a unit qualifier and the quantityPackage 68071-5109-01. 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)
Amoxicillin for oral suspension is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 - 1.4 ) In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin for oral suspension 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. ( 1.6 ) 1.1 Infections of the Ear, No…
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 | 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 400 mg/5mL | Powder, For suspensionOral | DirectRx | 72189-285 |
| 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 |