Prescription drug · ANDA
Amoxicillin NDC 70518-4279
Amoxicillin 500 mg/1 · Capsule · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4279-0 | 70518427900 | 100 POUCH in 1 BOX (70518-4279-0) / 1 CAPSULE in 1 POUCH (70518-4279-1)Marketed from Feb 6, 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 065291
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 70518-4279_5a95270a-c24d-1f5c-e063-6394a90a91c9SPL ID 5a95270a-c24d-1f5c-e063-6394a90a91c9SPL set ID b6ea2f81-aee6-4c88-b681-50eb28e80a86RxCUI 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
N470518427900followed by a unit qualifier and the quantityPackage 70518-4279-00. 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)
Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species. (α-and β‑-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp. , or Haemophilus influenzae . Infections of the Genitourinary Tract : Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis . Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due t…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065291
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 | Hikma Pharmaceuticals USA Inc. | 0143-9939 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-225 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0303 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0301 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0302 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0304 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-254 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-254 |