Prescription drug · ANDA
Amantadine Hydrochloride NDC 16571-834
Amantadine hydrochloride 100 mg/1 · Capsule · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-834-01 | 16571083401 | 100 CAPSULE in 1 BOTTLE (16571-834-01)Marketed from Sep 5, 2022 | |
| 16571-834-50 | 16571083450 | 500 CAPSULE in 1 BOTTLE (16571-834-50)Marketed from Sep 5, 2022 |
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/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210129
- Marketing start
- Listing expires
- Other FDA classes
- M2 Protein Inhibitors (Mechanism)
- Identifiers
- Product ID 16571-834_1a920249-de25-4d4e-b515-4fcbf3ead399SPL ID 1a920249-de25-4d4e-b515-4fcbf3ead399SPL set ID 6fd54e00-a714-4442-af95-2515ab3b2ac3RxCUI 849389UNII M6Q1EO9TD0UPC 0316571834013, 0316571834501
- 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
N416571083401followed by a unit qualifier and the quantityPackage 16571-0834-01. 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)
INDICATIONS AND USAGE Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules, USP are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine 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 protecte…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210129
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 100 mg/1 | Capsule, Gelatin coatedOral | Marlex Pharmaceuticals Inc | 10135-693 |
| Amantadine HCL | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Direct RX | 72189-657 |