Prescription drug · ANDA
Amantadine NDC 0116-4010
Amantadine hydrochloride 50 mg/5mL · Solution · Oral · Xttrium Laboratories, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0116-4010-16 | 00116401016 | 473 mL in 1 BOTTLE (0116-4010-16)Marketed from Nov 5, 2024 | |
| 0116-4010-41 | 00116401041 | 100 TRAY in 1 CASE (0116-4010-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4010-10)Marketed from Nov 5, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Amantadine
- Generic name (nonproprietary)
- amantadine
- Active ingredients
- Amantadine hydrochloride — 50 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Xttrium Laboratories, Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075060
- Marketing start
- Listing expires
- Other FDA classes
- M2 Protein Inhibitors (Mechanism)
- Identifiers
- Product ID 0116-4010_3479947d-22a8-67e8-e063-6294a90ae41cSPL ID 3479947d-22a8-67e8-e063-6294a90ae41cSPL set ID 25dd8a3c-6b11-2ea1-e063-6294a90a50cfRxCUI 849385UNII M6Q1EO9TD0UPC 0001164010164
- Pharmacologic class
- Influenza A M2 Protein Inhibitor
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
N400116401016followed by a unit qualifier and the quantityPackage 00116-4010-16. 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)
Indications and Usage Amantadine Hydrochloride Oral Solution, USP is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis: Amantadine hydrochloride is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when late…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075060
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 |
|---|---|---|---|---|
| Amantadine | Amantadine hydrochloride 50 mg/5mL | SolutionOral | AvPAK | 50268-036 |