Prescription drug · ANDA
amantadine NDC 62332-246
Amantadine hydrochloride 100 mg/1 · Capsule · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-246-30 | 62332024630 | 30 CAPSULE in 1 BOTTLE (62332-246-30)Marketed from Jun 22, 2017 | |
| 62332-246-31 | 62332024631 | 100 CAPSULE in 1 BOTTLE (62332-246-31)Marketed from Jun 22, 2017 | |
| 62332-246-71 | 62332024671 | 500 CAPSULE in 1 BOTTLE (62332-246-71)Marketed from Jun 22, 2017 | |
| 62332-246-91 | 62332024691 | 1000 CAPSULE in 1 BOTTLE (62332-246-91)Marketed from Jun 22, 2017 |
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
- Generic name (nonproprietary)
- amantadine
- Active ingredients
- Amantadine hydrochloride — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208966
- Marketing start
- Listing expires
- Other FDA classes
- M2 Protein Inhibitors (Mechanism)
- Identifiers
- Product ID 62332-246_416dbd88-4408-43c2-b47d-c14911c050d0SPL ID 416dbd88-4408-43c2-b47d-c14911c050d0SPL set ID 4157d9a7-a53f-4dde-b051-fe3e9a674913RxCUI 849389UNII M6Q1EO9TD0UPC 0362332246304
- 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
N462332024630followed by a unit qualifier and the quantityPackage 62332-0246-30. 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 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 later ex…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208966
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 100 mg/1 | CapsuleOral | American Health Packaging | 60687-422 |
| amantadine | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-246 |