Prescription drug · ANDA
Amoxicillin NDC 68071-2558
Amoxicillin 250 mg/5mL · Powder, For suspension · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-2558-5 | 68071255805 | 150 mL in 1 BOTTLE (68071-2558-5)Marketed from Oct 28, 2021 |
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 — 250 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 061931
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 68071-2558_2dcc5889-6ad9-d3dc-e063-6294a90a50f7SPL ID 2dcc5889-6ad9-d3dc-e063-6294a90a50f7SPL set ID cf707c13-3b40-079c-e053-2995a90a2176RxCUI 239191UNII 804826J2HUUPC 0368071255850
- 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
N468071255805followed by a unit qualifier and the quantityPackage 68071-2558-05. 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 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 to 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 capsules, amoxicillin for oral suspension, amoxicillin tablets (chewable) and other antibacterial drugs, amoxicillin capsules, amoxicillin for oral suspension, and amoxicillin tablets (chewable) should be used only to treat infections that are…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 061931
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 | NuCare Pharmaceuticals,Inc. | 66267-994 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | Chartwell RX, LLC | 62135-089 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | Chartwell RX, LLC | 62135-109 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | Asclemed USA, Inc. | 76420-573 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 63187-186 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | Teva Pharmaceuticals USA, Inc. | 0093-4155 |