Prescription drug · ANDA
Oseltamivir NDC 46708-414
Oseltamivir phosphate 45 mg/1 · Capsule · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-414-10 | 46708041410 | 1 CARTON in 1 BLISTER PACK (46708-414-10) / 10 CAPSULE in 1 CARTONMarketed from Jun 25, 2019 |
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
- Active ingredients
- Oseltamivir phosphate — 45 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211823
- Marketing start
- Listing expires
- Other FDA classes
- Neuraminidase Inhibitors (Mechanism)
- Identifiers
- Product ID 46708-414_d5e4bb9c-4af2-407a-8c7d-d4c9cb5117f5SPL ID d5e4bb9c-4af2-407a-8c7d-d4c9cb5117f5SPL set ID 0a7181a6-e9eb-4047-a26f-4268f174db16RxCUI 312122, 728109, 728113UNII 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
N446708041410followed by a unit qualifier and the quantityPackage 46708-0414-10. 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 capsule 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 capsules are indicated for the treatment of a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211823
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 | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-413 |
| Oseltamivir | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-415 |
| Oseltamivir | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-414 |
| Oseltamivir | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-413 |
| Oseltamivir | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-415 |