Prescription drug · ANDA
Oseltamivir phosphate NDC 82804-180
Oseltamivir phosphate 75 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-180-10 | 82804018010 | 1 BLISTER PACK in 1 CARTON (82804-180-10) / 10 CAPSULE in 1 BLISTER PACKMarketed from Dec 27, 2024 |
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
- Labeler
- Proficient Rx LPNDC labeler code 82804
- 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 82804-180_37eb95bb-3142-4355-8057-4e7c78443641SPL ID 37eb95bb-3142-4355-8057-4e7c78443641SPL set ID 37eb95bb-3142-4355-8057-4e7c78443641RxCUI 312122UNII 4A3O49NGEZUPC 0382804180103
- 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
N482804018010followed by a unit qualifier and the quantityPackage 82804-0180-10. 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 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 82804-180
- What is NDC 82804-180?
- 82804-180 is the product NDC for Oseltamivir phosphate, Oseltamivir phosphate 75 mg/1 capsule, listed with the FDA by Proficient Rx LP. 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?
- Proficient Rx LP, NDC labeler code 82804. 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 45 mg/1 | CapsuleOral | MSN LABORATORIES PRIVATE LIMITED | 69539-110 |
| 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 |