Prescription drug · ANDA
oseltamavir phosphate NDC 68071-3741
Oseltamivir phosphate 45 mg/1 · Capsule · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3741-1 | 68071374101 | 1 BLISTER PACK in 1 CARTON (68071-3741-1) / 10 CAPSULE in 1 BLISTER PACKMarketed from Dec 9, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- oseltamavir phosphate
- Generic name (nonproprietary)
- oseltamavir phosphate
- Active ingredients
- Oseltamivir phosphate — 45 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207211
- Marketing start
- Listing expires
- Other FDA classes
- Neuraminidase Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-3741_28dd9191-b186-b651-e063-6394a90a3831SPL ID 28dd9191-b186-b651-e063-6394a90a3831SPL set ID 28ddaeb7-5903-4b59-e063-6294a90a2bcdRxCUI 728113UNII 4A3O49NGEZUPC 0368071374117
- 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
N468071374101followed by a unit qualifier and the quantityPackage 68071-3741-01. 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 capsule is indicated for the treat…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207211
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 |
|---|---|---|---|---|
| oseltamavir phosphate | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Proficient Rx LP | 71205-417 |
| oseltamavir phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4739 |
| oseltamavir phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Proficient Rx LP | 71205-107 |
| oseltamivir phosphate | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-257 |
| oseltamivir phosphate | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-256 |
| oseltamivir phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-258 |