Prescription drug · ANDA
oseltamivir phosphate NDC 33342-257
Oseltamivir phosphate 45 mg/1 · Capsule · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-257-66 | 33342025766 | 1 BLISTER PACK in 1 CARTON (33342-257-66) / 10 CAPSULE in 1 BLISTER PACKMarketed from Sep 21, 2017 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207211
- Marketing start
- Listing expires
- Other FDA classes
- Neuraminidase Inhibitors (Mechanism)
- Identifiers
- Product ID 33342-257_e6722163-0760-4653-bab9-1bb1a603e935SPL ID e6722163-0760-4653-bab9-1bb1a603e935SPL set ID e9307620-36bd-46c2-a8b2-027d3fba87baRxCUI 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.
- NDC on a medical claim
N433342025766followed by a unit qualifier and the quantityPackage 33342-0257-66. 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 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 capsule is indicated for the treat…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207211
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 |
|---|---|---|---|---|
| oseltamavir phosphate | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Proficient Rx LP | 71205-417 |
| oseltamavir phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4739 |
| oseltamavir phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Proficient Rx LP | 71205-107 |
| oseltamivir phosphate | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-256 |
| oseltamivir phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-258 |
| oseltamavir phosphate | Oseltamivir phosphate 45 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3741 |