Prescription drug · ANDA
Oseltamivir Phosphate for Oral Suspension (Oseltamivir phosphate) NDC 47781-384
Oseltamivir phosphate 6 mg/mL · Powder, For suspension · Oral · Alvogen Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47781-384-26 | 47781038426 | 1 BOTTLE, GLASS in 1 CARTON (47781-384-26) / 60 mL in 1 BOTTLE, GLASSMarketed from Nov 1, 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 for Oral Suspension
- Generic name (nonproprietary)
- oseltamivir phosphate
- Active ingredients
- Oseltamivir phosphate — 6 mg/mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Alvogen Inc.NDC labeler code 47781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208823
- Marketing start
- Listing expires
- Other FDA classes
- Neuraminidase Inhibitors (Mechanism)
- Identifiers
- Product ID 47781-384_bc6ab861-892d-407f-7187-e7a9e31bd593SPL ID bc6ab861-892d-407f-7187-e7a9e31bd593SPL set ID 82df3237-636b-7bf9-3ba0-2b476e74bf4cRxCUI 1115698UNII 4A3O49NGEZUPC 0347781384265
- 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
N447781038426followed by a unit qualifier and the quantityPackage 47781-0384-26. 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 for oral suspension 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 for oral suspension is i…
Excerpt only. Read the full label for complete information.
About NDC 47781-384
- What is NDC 47781-384?
- 47781-384 is the product NDC for Oseltamivir Phosphate for Oral Suspension, Oseltamivir phosphate 6 mg/mL powder, for suspension, listed with the FDA by Alvogen Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oseltamivir Phosphate for Oral Suspension (Oseltamivir Phosphate).
- What is the active ingredient?
- Oseltamivir phosphate.
- Who is the labeler?
- Alvogen Inc., NDC labeler code 47781. 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 for Oral Suspension?
- 3 other product NDCs are listed under this name. See all Oseltamivir Phosphate for Oral Suspension 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 for Oral Suspension 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 for Oral Suspensionoseltamivir phosphate | Oseltamivir phosphate 6 mg/mL | Powder, For suspensionOral | Oryza Pharmaceuticals Inc. | 72516-029 | 72516-0029-01 |
| Oseltamivir Phosphate for Oral Suspensionoseltamivir phosphate | Oseltamivir phosphate 6 mg/mL | Powder, For suspensionOral | EPIC PHARMA, LLC | 42806-363 | 42806-0363-13 |
| Oseltamivir Phosphate for Oral Suspensionoseltamivir phosphate | Oseltamivir phosphate 6 mg/mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-3724 | 68071-3724-06 |
Other NDCs under ANDA 208823
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 for Oral Suspensionoseltamivir phosphate | Oseltamivir phosphate 6 mg/mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-3724 |