Prescription drug · ANDA
Amoxicillin NDC 76420-819
Amoxicillin 400 mg/5mL · Powder, For suspension · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-819-01 | 76420081901 | 100 mL in 1 BOTTLE (76420-819-01)Marketed from Jun 26, 2024 | |
| 76420-819-50 | 76420081950 | 50 mL in 1 BOTTLE (76420-819-50)Marketed from Jun 26, 2024 | |
| 76420-819-75 | 76420081975 | 75 mL in 1 BOTTLE (76420-819-75)Marketed from Jun 26, 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 — 400 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065378
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 76420-819_1bc435f9-12b8-ccff-e063-6294a90a951aSPL ID 1bc435f9-12b8-ccff-e063-6294a90a951aSPL set ID 830bb8fb-3743-463a-9317-3f83e3e105acRxCUI 308189UNII 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
N476420081901followed by a unit qualifier and the quantityPackage 76420-0819-01. 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 is 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 is 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 is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negat…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065378
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 400 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-5127 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | REMEDYREPACK INC. | 70518-4521 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 71205-436 |
| Amoxicillin | Amoxicillin 200 mg/5mL | Powder, For suspensionOral | Sandoz Inc | 0781-6156 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | Sandoz Inc | 0781-6157 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | HAWAII REPACK, INC. | 85534-0073 |
| Amoxicillin | Amoxicillin 200 mg/5mL | Powder, For suspensionOral | HAWAII REPACK, INC. | 85534-0071 |