Prescription drug · ANDA
Amantadine Hydrochloride NDC 68999-011
Amantadine hydrochloride 100 mg/10mL · Solution · Oral · Chartwell Governmental & Specialty RX, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68999-011-24 | 68999001124 | 2 TRAY in 1 BOX (68999-011-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68999-011-59)Marketed from Dec 17, 2025 |
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)
- Amantadine Hydrochloride
- Generic name (nonproprietary)
- amantadine hydrochloride
- Active ingredients
- Amantadine hydrochloride — 100 mg/10mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074028
- Marketing start
- Listing expires
- Other FDA classes
- M2 Protein Inhibitors (Mechanism)
- Identifiers
- Product ID 68999-011_4651addb-4284-88e1-e063-6294a90a3d13SPL ID 4651addb-4284-88e1-e063-6294a90a3d13SPL set ID 3c448cb3-7996-4a83-a9ad-23a00a431fbeRxCUI 849385UNII M6Q1EO9TD0
- 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
N468999001124followed by a unit qualifier and the quantityPackage 68999-0011-24. 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 is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride oral solution is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride oral solution is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride oral solution 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 vaccin…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074028
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 Hydrochloride | Amantadine hydrochloride 50 mg/5mL | SolutionOral | Chartwell RX, LLC | 62135-010 |
| Amantadine Hydrochloride | Amantadine hydrochloride 100 mg/10mL | SolutionOral | Chartwell RX, LLC | 62135-011 |