Prescription drug · ANDA
Amoxicillin NDC 76420-833
Amoxicillin 500 mg/1 · Capsule · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-833-01 | 76420083301 | 100 CAPSULE in 1 BOTTLE (76420-833-01)Marketed from Aug 14, 2024 | |
| 76420-833-05 | 76420083305 | 500 CAPSULE in 1 BOTTLE (76420-833-05)Marketed from Aug 14, 2024 | |
| 76420-833-20 | 76420083320 | 20 CAPSULE in 1 BOTTLE (76420-833-20)Marketed from Aug 14, 2024 | |
| 76420-833-30 | 76420083330 | 30 CAPSULE in 1 BOTTLE (76420-833-30)Marketed from Aug 14, 2024 | |
| 76420-833-50 | 76420083350 | 50 CAPSULE in 1 BOTTLE (76420-833-50)Marketed from Aug 14, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Asclemed USA, 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 76420-833_1f9dd2b3-12f6-c5c3-e063-6294a90a8065SPL ID 1f9dd2b3-12f6-c5c3-e063-6294a90a8065SPL set ID 9cd42f6f-cc7a-43f5-98dd-a5d6210933aeRxCUI 308182, 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
N476420083301followed by a unit qualifier and the quantityPackage 76420-0833-01. 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 to…
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 | NuCare Pharmaceuticals,Inc. | 68071-4455 |
| 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 |
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