Prescription drug · ANDA
Amoxicillin NDC 68071-4455
Amoxicillin 500 mg/1 · Capsule · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4455-0 | 68071445500 | 10 CAPSULE in 1 BOTTLE (68071-4455-0)Marketed from May 30, 2018 | |
| 68071-4455-1 | 68071445501 | 21 CAPSULE in 1 BOTTLE (68071-4455-1)Marketed from May 30, 2018 | |
| 68071-4455-2 | 68071445502 | 20 CAPSULE in 1 BOTTLE (68071-4455-2)Marketed from May 30, 2018 | |
| 68071-4455-3 | 68071445503 | 30 CAPSULE in 1 BOTTLE (68071-4455-3)Marketed from May 30, 2018 | |
| 68071-4455-4 | 68071445504 | 40 CAPSULE in 1 BOTTLE (68071-4455-4)Marketed from May 30, 2018 | |
| 68071-4455-5 | 68071445505 | 56 CAPSULE in 1 BOTTLE (68071-4455-5)Marketed from May 30, 2018 | |
| 68071-4455-6 | 68071445506 | 60 CAPSULE in 1 BOTTLE (68071-4455-6)Marketed from May 30, 2018 | |
| 68071-4455-7 | 68071445507 | 15 CAPSULE in 1 BOTTLE (68071-4455-7)Marketed from May 30, 2018 | |
| 68071-4455-8 | 68071445508 | 28 CAPSULE in 1 BOTTLE (68071-4455-8)Marketed from May 30, 2018 |
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 — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065271
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 68071-4455_2b37005a-55d9-d329-e063-6294a90af0daSPL ID 2b37005a-55d9-d329-e063-6294a90af0daSPL set ID 6d7143e3-6a82-3613-e053-2a91aa0a8f65RxCUI 308191UNII 804826J2HUUPC 0368071445527
- 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
N468071445500followed by a unit qualifier and the quantityPackage 68071-4455-00. 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 capsules 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 – 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 and other antibacterial drugs, amoxicillin capsules 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 capsules ar…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065271
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 500 mg/1 | CapsuleOral | Sportpharm LLC | 85766-021 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Sportpharm LLC | 85766-267 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-820 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1795 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1794 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1810 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1796 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1797 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1813 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1811 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1812 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1826 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3832 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0895 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-915 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3235 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | NuCare Pharmaceutials,Inc. | 68071-3662 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Northwind Pharmaceuticals, LLC | 51655-156 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4698 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Preferred Phamraceuticals Inc. | 68788-8209 |
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