Prescription drug · ANDA
Oseltamivir Phosphate (Oseltamivir) NDC 60219-1265
Oseltamivir phosphate 45 mg/1 · Capsule · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60219-1265-1 | 60219126501 | 1 BLISTER PACK in 1 CARTON (60219-1265-1) / 10 CAPSULE in 1 BLISTER PACKMarketed from Sep 27, 2022 |
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)
- Oseltamivir Phosphate
- Generic name (nonproprietary)
- oseltamivir
- Active ingredients
- Oseltamivir phosphate — 45 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 60219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209093
- Marketing start
- Listing expires
- Other FDA classes
- Neuraminidase Inhibitors (Mechanism)
- Identifiers
- Product ID 60219-1265_140eca94-b0b9-491c-afa2-c4325b580972SPL ID 140eca94-b0b9-491c-afa2-c4325b580972SPL set ID 8ca926e0-4c3c-473f-9cd0-ff38032d6963RxCUI 312122, 728109, 728113UNII 4A3O49NGEZUPC 0360219126619, 0360219126411, 0360219126510
- 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
N460219126501followed by a unit qualifier and the quantityPackage 60219-1265-01. 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 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 treatment of…
Excerpt only. Read the full label for complete information.
About NDC 60219-1265
- What is NDC 60219-1265?
- 60219-1265 is the product NDC for Oseltamivir Phosphate (oseltamivir), Oseltamivir phosphate 45 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oseltamivir Phosphate (Oseltamivir).
- What is the active ingredient?
- Oseltamivir phosphate.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 60219. 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 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 209093
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 Phosphateoseltamivir | Oseltamivir phosphate 75 mg/1 | CapsuleOral | AvKARE | 42291-664 |
| Oseltamivir Phosphateoseltamivir | Oseltamivir phosphate 30 mg/1 | CapsuleOral | AvKARE | 42291-666 |
| Oseltamivir Phosphateoseltamivir | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1264 |
| Oseltamivir Phosphateoseltamivir | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1266 |
| Oseltamivir Phosphateoseltamivir | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1264 |
| Oseltamivir Phosphateoseltamivir | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1265 |
| Oseltamivir Phosphateoseltamivir | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1266 |