Prescription drug · ANDA
oseltamavir phosphate NDC 68071-4739
Oseltamivir phosphate 75 mg/1 · Capsule · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4739-1 | 6807147390168071473901 | 10 CAPSULE in 1 BOX (68071-4739-1)Marketed from Jan 25, 2019 |
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)
- oseltamavir phosphate
- Generic name (nonproprietary)
- oseltamavir phosphate
- Active ingredients
- Oseltamivir phosphate — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- 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 68071-4739_2d7d2d42-1baa-e20a-e063-6394a90a15ccSPL ID 2d7d2d42-1baa-e20a-e063-6394a90a15ccSPL set ID 80511c6f-88b9-62d3-e053-2991aa0ab936RxCUI 312122UNII 4A3O49NGEZUPC 0368071473919
- 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
N468071473901followed by a unit qualifier and the quantityPackage 68071-4739-01. 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 USP, 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…
Excerpt only. Read the full label for complete information.
About NDC 68071-4739
- What is NDC 68071-4739?
- 68071-4739 is the product NDC for oseltamavir phosphate, Oseltamivir phosphate 75 mg/1 capsule, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- oseltamavir phosphate.
- What is the active ingredient?
- Oseltamivir phosphate.
- Who is the labeler?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for oseltamavir phosphate?
- 3 other product NDCs are listed under this name. See all oseltamavir phosphate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other oseltamavir 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) |
|---|---|---|---|---|---|
| oseltamavir phosphate | Oseltamivir phosphate 45 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3741 | 68071-3741-01 |
| oseltamavir phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Proficient Rx LP | 71205-107 | 71205-0107-1071205-0107-3071205-0107-60+1 more |
| oseltamavir phosphate | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Proficient Rx LP | 71205-417 | 71205-0417-10 |
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 | NuCare Pharmaceuticals, Inc. | 68071-3741 |
| oseltamavir phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Proficient Rx LP | 71205-107 |
| oseltamavir phosphate | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Proficient Rx LP | 71205-417 |
| oseltamivir phosphate | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-256 |
| oseltamivir phosphate | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-257 |
| oseltamivir phosphate | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-258 |