Prescription drug · ANDA
Oseltamivir phosphate NDC 42677-321
Oseltamivir phosphate 45 mg/1 · Capsule · Oral · Shandong New Time Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42677-321-01 | 42677032101 | 1 BLISTER PACK in 1 CARTON (42677-321-01) / 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 — 45 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Shandong New Time Pharmaceutical Co., Ltd.NDC labeler code 42677
- 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 42677-321_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
N442677032101followed by a unit qualifier and the quantityPackage 42677-0321-01. 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.
About NDC 42677-321
- What is NDC 42677-321?
- 42677-321 is the product NDC for Oseltamivir phosphate, Oseltamivir phosphate 45 mg/1 capsule, listed with the FDA by Shandong New Time Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oseltamivir phosphate.
- What is the active ingredient?
- Oseltamivir phosphate.
- Who is the labeler?
- Shandong New Time Pharmaceutical Co., Ltd., NDC labeler code 42677. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oseltamivir phosphate?
- 105 other product NDCs are listed under this name. See all Oseltamivir phosphate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oseltamivir phosphate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oseltamivir Phosphate | Oseltamivir phosphate 6 mg/mL | For suspensionOral | Alembic Pharmaceuticals Limited | 46708-769 | 46708-0769-60 |
| Oseltamivir Phosphate | Oseltamivir phosphate 6 mg/mL | For suspensionOral | Alembic Pharmaceuticals Inc. | 62332-769 | 62332-0769-60 |
| Oseltamivir Phosphate | Oseltamivir phosphate 6 mg/mL | SuspensionOral | HEC Pharm USA Inc. | 72303-0851 | 72303-0851-01 |
| Oseltamivir Phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4066 | 68788-4066-01 |
| oseltamivir phosphate | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Zhejiang Poly Pharm. Co., Ltd. | 72673-101 | 72673-0101-10 |
| oseltamivir phosphate | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Zhejiang Poly Pharm. Co., Ltd. | 72673-102 | 72673-0102-10 |
| Oseltamivir phosphate | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Shandong New Time Pharmaceutical Co., Ltd. | 42677-320 | 42677-0320-01 |
| Oseltamivir phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Shandong New Time Pharmaceutical Co., Ltd. | 42677-322 | 42677-0322-01 |
| Oseltamivir phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8831 | 68788-8831-01 |
| Oseltamivir Phosphate | Oseltamivir phosphate 6 mg/mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 59651-597 | 59651-0597-60 |
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 75 mg/1 | CapsuleOral | Shandong New Time Pharmaceutical Co., Ltd. | 42677-322 |