Prescription drug · ANDA
Oseltamivir Phosphate NDC 76282-739
Oseltamivir phosphate 6 mg/mL · For suspension · Oral · Exelan Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-739-52 | 76282073952 | 1 BOTTLE in 1 CARTON (76282-739-52) / 60 mL in 1 BOTTLEMarketed from Dec 1, 2023 |
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 phosphate
- Active ingredients
- Oseltamivir phosphate — 6 mg/mL
- Dosage form
- For suspension
- Route
- Oral
- Labeler
- Exelan Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212858
- Marketing start
- Listing expires
- Other FDA classes
- Neuraminidase Inhibitors (Mechanism)
- Identifiers
- Product ID 76282-739_b9fa33ae-039e-4192-bda0-7797932d2653SPL ID b9fa33ae-039e-4192-bda0-7797932d2653SPL set ID 9fb09e82-42ef-4a2a-9bcd-3aab3ac52bb3RxCUI 1115698UNII 4A3O49NGEZUPC 0376282739526
- 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
N476282073952followed by a unit qualifier and the quantityPackage 76282-0739-52. 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 for Oral Suspension 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 Oseltamivir Phosphate for Oral Suspension is …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212858
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 Phosphate | Oseltamivir phosphate 6 mg/mL | For suspensionOral | Cipla USA, Inc | 69097-904 |