Prescription drug · ANDA
Amoxicillin NDC 70518-4371
Amoxicillin 500 mg/1 · Capsule · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4371-0 | 70518437100 | 30 CAPSULE in 1 BOTTLE, PLASTIC (70518-4371-0)Marketed from Jun 25, 2025 |
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
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062216
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 70518-4371_5b0d4963-eecd-294e-e063-6294a90a87b4SPL ID 5b0d4963-eecd-294e-e063-6294a90a87b4SPL set ID 4adc198e-39d8-4b3e-bfa4-278aaf4064aeRxCUI 308191UNII 804826J2HU
- 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
N470518437100followed by a unit qualifier and the quantityPackage 70518-4371-00. 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 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 and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Infections of the Ear, Nose, and Throat: Amoxicillin is indicated in the …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 062216
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 | USAntibiotics, LLC | 81964-205 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | USAntibiotics, LLC | 81964-350 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | USAntibiotics, LLC | 81964-225 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Redpharm Drug | 67296-1914 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Redpharm Drug | 67296-1914 |