Prescription drug · ANDA
Rimantadine Hydrochloride NDC 0115-1911
Rimantadine hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0115-1911-01 | 00115191101 | 100 TABLET, FILM COATED in 1 BOTTLE (0115-1911-01)Marketed from Nov 16, 2021 | |
| 0115-1911-02 | 00115191102 | 500 TABLET, FILM COATED in 1 BOTTLE (0115-1911-02)Marketed from Nov 16, 2021 |
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)
- Rimantadine Hydrochloride
- Generic name (nonproprietary)
- rimantadine hydrochloride
- Active ingredients
- Rimantadine hydrochloride — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076132
- Marketing start
- Listing expires
- Other FDA classes
- M2 Protein Inhibitors (Mechanism)
- Identifiers
- Product ID 0115-1911_b5f5cd6c-3874-4507-bbd4-72e8c5bfe17fSPL ID b5f5cd6c-3874-4507-bbd4-72e8c5bfe17fSPL set ID 49f7d69a-820b-4c75-a31d-b2104c019c12RxCUI 856605UNII JEI07OOS8Y
- 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
N400115191101followed by a unit qualifier and the quantityPackage 00115-1911-01. 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 Rimantadine hydrochloride tablet is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults (17 years and older). Rimantadine hydrochloride tablet is indicated for prophylaxis against influenza A virus in children (1 year to 16 years of age). Prophylaxis In controlled studies of children (1 year to 16 years of age), healthy adults (17 years and older), and elderly patients (65 years of age and older), rimantadine hydrochloride has been shown to be safe and effective in preventing signs and symptoms of infection caused by various strains of influenza A virus. Since rimantadine hydrochloride does not completely preve…
Excerpt only. Read the full label for complete information.