Prescription drug · ANDA
Oseltamivir phosphate NDC 42677-322
Oseltamivir phosphate 75 mg/1 · Capsule · Oral · Shandong New Time Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42677-322-01 | 42677032201 | 1 BLISTER PACK in 1 CARTON (42677-322-01) / 10 CAPSULE in 1 BLISTER PACKMarketed from Jul 9, 2025 |
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 — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217274
- Marketing start
- Listing expires
- Other FDA classes
- Neuraminidase Inhibitors (Mechanism)
- Identifiers
- Product ID 42677-322_53b48bb4-e38e-bf3e-e063-6394a90a2cfbSPL ID 53b48bb4-e38e-bf3e-e063-6394a90a2cfbSPL set ID 61b673d9-4787-4bc8-bf9e-2cfef0326911RxCUI 312122, 728109, 728113UNII 4A3O49NGEZUPC 0342677320013
- 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
N442677032201followed by a unit qualifier and the quantityPackage 42677-0322-01. 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 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 ac…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217274
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 30 mg/1 | CapsuleOral | Shandong New Time Pharmaceutical Co., Ltd. | 42677-320 |
| Oseltamivir phosphate | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Shandong New Time Pharmaceutical Co., Ltd. | 42677-321 |
- 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.