Prescription drug · NDA
Tamiflu (oseltamivir phosphate) NDC 0004-0802
Oseltamivir phosphate 30 mg/1 · Capsule · Oral · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0004-0802-85 | 00004080285 | 1 BLISTER PACK in 1 CARTON (0004-0802-85) / 10 CAPSULE in 1 BLISTER PACKMarketed from Oct 27, 1999 |
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)
- Tamiflu
- Generic name (nonproprietary)
- oseltamivir phosphate
- Active ingredients
- Oseltamivir phosphate — 30 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Genentech, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021087
- Marketing start
- Listing expires
- Other FDA classes
- Neuraminidase Inhibitors (Mechanism)
- Identifiers
- Product ID 0004-0802_94a312ac-c47a-4437-8dd3-6bcd7e08e42cSPL ID 94a312ac-c47a-4437-8dd3-6bcd7e08e42cSPL set ID ee3c9555-60f2-4f82-a760-11983c86e97bRxCUI 261315, 312122, 728109, 728111, 728113, 728115, 1115698, 1115700UNII 4A3O49NGEZ
- 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
N400004080285followed by a unit qualifier and the quantityPackage 00004-0802-85. 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)
TAMIFLU is 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 TAMIFLU is indicated for the treatment of acute, uncomplicated illness due to i…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021087
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 |
|---|---|---|---|---|
| Tamifluoseltamivir phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Genentech, Inc. | 0004-0800 |