Prescription drug · ANDA
Amoxicillin NDC 68071-4982
Amoxicillin 875 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4982-2 | 68071498202 | 20 TABLET, FILM COATED in 1 BOTTLE (68071-4982-2)Marketed from Jul 24, 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 — 875 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065256
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 68071-4982_44fcbea4-7615-1d98-e063-6294a90a6b32SPL ID 44fcbea4-7615-1d98-e063-6294a90a6b32SPL set ID 8e6f9df1-0754-69e4-e053-2a95a90acc49RxCUI 308194UNII 804826J2HUUPC 0368071498226
- 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
N468071498202followed by a unit qualifier and the quantityPackage 68071-4982-02. 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 tablets are 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 tablets and other antibacterial drugs, amoxicillin tablets 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, Nose, and Throat Amoxicillin tablets…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065256
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 875 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0015 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5096 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3872 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1825 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0714 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2191 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-729 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-325 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3886 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4777 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7414 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3675 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2333 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-003 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-028 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0734 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-029 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-015 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-014 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0713 |
Showing 20 of 29.