Prescription drug · ANDA
Oseltamivir (oseltamivir phosphate) NDC 42385-986
Oseltamivir phosphate 45 mg/1 · Capsule · Oral · Laurus Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42385-986-01 | 42385098601 | 100 CAPSULE in 1 BOTTLE (42385-986-01)Marketed from May 2, 2024 | |
| 42385-986-11 | 42385098611 | 1 BLISTER PACK in 1 CARTON (42385-986-11) / 10 CAPSULE in 1 BLISTER PACK (42385-986-10)Marketed from May 2, 2024 |
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
- Generic name (nonproprietary)
- oseltamivir phosphate
- Active ingredients
- Oseltamivir phosphate — 45 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Laurus Labs Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218565
- Marketing start
- Listing expires
- Other FDA classes
- Neuraminidase Inhibitors (Mechanism)
- Identifiers
- Product ID 42385-986_60c86f43-ed69-4ae2-a717-b096cb6bd47eSPL ID 60c86f43-ed69-4ae2-a717-b096cb6bd47eSPL set ID 927cba3a-62cf-4e9f-9871-92835927ea46RxCUI 312122, 728109, 728113UNII 4A3O49NGEZUPC 0342385987010, 0342385985016
- 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
N442385098601followed by a unit qualifier and the quantityPackage 42385-0986-01. 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)
Oseltamivir phosphate 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 is indicated for the treatment of acute, un…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218565
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 |
|---|---|---|---|---|
| Oseltamiviroseltamivir phosphate | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Laurus Labs Limited | 42385-985 |
| Oseltamiviroseltamivir phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Laurus Labs Limited | 42385-987 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.