Prescription drug · ANDA
Amantadine Hydrochloride NDC 0832-1015
Amantadine hydrochloride 100 mg/1 · Capsule, Gelatin coated · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-1015-00 | 00832101500 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (0832-1015-00)Marketed from Sep 15, 2011 | |
| 0832-1015-50 | 00832101550 | 500 CAPSULE, GELATIN COATED in 1 BOTTLE (0832-1015-50)Marketed from Sep 15, 2011 |
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 Hydrochloride
- Generic name (nonproprietary)
- amantadine hydrochloride
- Active ingredients
- Amantadine hydrochloride — 100 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070589
- Marketing start
- Marketing end
- Other FDA classes
- M2 Protein Inhibitors (Mechanism)
- Identifiers
- Product ID 0832-1015_398493aa-8a67-10e2-e063-6394a90aef8dSPL ID 398493aa-8a67-10e2-e063-6394a90aef8dSPL set ID 5232b933-1df9-43b4-8ac2-61bfa4855e68RxCUI 849389UNII M6Q1EO9TD0UPC 0308321015001
- 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
N400832101500followed by a unit qualifier and the quantityPackage 00832-1015-00. 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)
INDICATIONS AND USAGE Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis: Amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride capsules do 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 p…
Excerpt only. Read the full label for complete information.