Prescription drug · ANDA
Oseltamivir Phosphate (oseltamivir) NDC 42291-664
Oseltamivir phosphate 75 mg/1 · Capsule · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-664-10 | 42291066410 | 10 CAPSULE in 1 BOX, UNIT-DOSE (42291-664-10)Marketed from Aug 8, 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)
- Oseltamivir Phosphate
- Generic name (nonproprietary)
- oseltamivir
- Active ingredients
- Oseltamivir phosphate — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209093
- Marketing start
- Listing expires
- Other FDA classes
- Neuraminidase Inhibitors (Mechanism)
- Identifiers
- Product ID 42291-664_487151fd-29d3-da81-e063-6394a90a2d8fSPL ID 487151fd-29d3-da81-e063-6394a90a2d8fSPL set ID c61bb5af-558f-4b32-b34d-8fdae480443cRxCUI 312122, 728109UNII 4A3O49NGEZUPC 0342291666108, 0342291664104
- Pharmacologic class
- Neuraminidase 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
N442291066410followed by a unit qualifier and the quantityPackage 42291-0664-10. 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)
Oseltamivir phosphate capsules are an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2) Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3) 1.1 Treatment of Influenza Oseltamivir phosphate capsules are indicated for the treatment of …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209093
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 |
|---|---|---|---|---|
| Oseltamivir Phosphateoseltamivir | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1266 |
| Oseltamivir Phosphateoseltamivir | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1264 |
| Oseltamivir Phosphateoseltamivir | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1265 |
| Oseltamivir Phosphateoseltamivir | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1264 |
| Oseltamivir Phosphateoseltamivir | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1265 |
| Oseltamivir Phosphateoseltamivir | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1266 |
| Oseltamivir Phosphateoseltamivir | Oseltamivir phosphate 30 mg/1 | CapsuleOral | AvKARE | 42291-666 |