Prescription drug · ANDA
Amoxicillin NDC 50090-6056
Amoxicillin 125 mg/5mL · Powder, For suspension · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6056-0 | 50090605600 | 150 mL in 1 BOTTLE (50090-6056-0)Marketed from Aug 25, 2022 |
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 — 125 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065387
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 50090-6056_eed9bf82-62ca-478b-b20b-12a0449249dbSPL ID eed9bf82-62ca-478b-b20b-12a0449249dbSPL set ID 8bac30bb-1dbc-41de-ad50-0a1883f96198RxCUI 313797UNII 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
N450090605600followed by a unit qualifier and the quantityPackage 50090-6056-00. 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 – 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 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 treatment…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065387
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 250 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-4581 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | Sandoz Inc | 0781-6039 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | Sandoz Inc | 0781-6041 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 63187-880 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals, Inc. | 68788-9949 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals, Inc. | 68788-9948 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-4969 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 71205-266 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | HAWAII REPACK, INC. | 85534-0070 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | HAWAII REPACK, INC. | 85534-0072 |