Prescription drug · ANDA
Oseltamivir phosphate NDC 69539-110
Oseltamivir phosphate 45 mg/1 · Capsule · Oral · MSN LABORATORIES PRIVATE LIMITED
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Oseltamivir phosphate
- Generic name (nonproprietary)
- oseltamivir phosphate
- Active ingredients
- Oseltamivir phosphate — 45 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- MSN LABORATORIES PRIVATE LIMITEDNDC labeler code 69539
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212544
- Marketing start
- Listing expires
- Other FDA classes
- Neuraminidase Inhibitors (Mechanism)
- Identifiers
- Product ID 69539-110_1eceb65e-b7b6-42ff-9fb7-2d47a6e978c3SPL ID 1eceb65e-b7b6-42ff-9fb7-2d47a6e978c3SPL set ID 1b7a02ca-ee0e-4853-91e6-71a79f2bc040RxCUI 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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Oseltamivir phosphate capsules are 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 tre…
Excerpt only. Read the full label for complete information.
About NDC 69539-110
- What is NDC 69539-110?
- 69539-110 is the product NDC for Oseltamivir phosphate, Oseltamivir phosphate 45 mg/1 capsule, listed with the FDA by MSN LABORATORIES PRIVATE LIMITED.
- What drug is associated with this NDC?
- Oseltamivir phosphate.
- What is the active ingredient?
- Oseltamivir phosphate.
- Who is the labeler?
- MSN LABORATORIES PRIVATE LIMITED, NDC labeler code 69539. 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 Inc. | 62332-769 | 62332-0769-60 |
| Oseltamivir Phosphate | Oseltamivir phosphate 6 mg/mL | For suspensionOral | Alembic Pharmaceuticals Limited | 46708-769 | 46708-0769-60 |
| 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 45 mg/1 | CapsuleOral | Shandong New Time Pharmaceutical Co., Ltd. | 42677-321 | 42677-0321-01 |
| 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 |
Other NDCs under ANDA 212544
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 75 mg/1 | CapsuleOral | Proficient Rx LP | 82804-180 |
| Oseltamivir phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8309 |
| Oseltamivir phosphate | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-042 |
| Oseltamivir phosphate | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-043 |
| Oseltamivir phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-044 |