Prescription drug · ANDA
Oseltamivir (Oseltamivir phosphate) NDC 42385-987
Oseltamivir phosphate 75 mg/1 · Capsule · Oral · Laurus Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42385-987-01 | 42385098701 | 100 CAPSULE in 1 BOTTLE (42385-987-01)Marketed from May 2, 2024 | |
| 42385-987-11 | 42385098711 | 1 BLISTER PACK in 1 CARTON (42385-987-11) / 10 CAPSULE in 1 BLISTER PACK (42385-987-10)Marketed from May 2, 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
- Generic name (nonproprietary)
- oseltamivir phosphate
- Active ingredients
- Oseltamivir phosphate — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Laurus Labs LimitedNDC labeler code 42385
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218565
- Marketing start
- Listing expires
- Other FDA classes
- Neuraminidase Inhibitors (Mechanism)
- Identifiers
- Product ID 42385-987_60c86f43-ed69-4ae2-a717-b096cb6bd47eSPL ID 60c86f43-ed69-4ae2-a717-b096cb6bd47eSPL set ID 927cba3a-62cf-4e9f-9871-92835927ea46RxCUI 312122, 728109, 728113UNII 4A3O49NGEZUPC 0342385987010, 0342385985016
- 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
N442385098701followed by a unit qualifier and the quantityPackage 42385-0987-01. 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 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 is indicated for the treatment of acute, un…
Excerpt only. Read the full label for complete information.
About NDC 42385-987
- What is NDC 42385-987?
- 42385-987 is the product NDC for Oseltamivir (oseltamivir phosphate), Oseltamivir phosphate 75 mg/1 capsule, listed with the FDA by Laurus Labs Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oseltamivir (Oseltamivir phosphate).
- What is the active ingredient?
- Oseltamivir phosphate.
- Who is the labeler?
- Laurus Labs Limited, NDC labeler code 42385. 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?
- 8 other product NDCs are listed under this name. See all Oseltamivir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oseltamivir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oseltamiviroseltamivir phosphate | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Laurus Labs Limited | 42385-985 | 42385-0985-0142385-0985-11 |
| Oseltamiviroseltamivir phosphate | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Laurus Labs Limited | 42385-986 | 42385-0986-0142385-0986-11 |
| Oseltamivir | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-413 | 46708-0413-10 |
| Oseltamivir | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-414 | 46708-0414-10 |
| Oseltamivir | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-415 | 46708-0415-10 |
| Oseltamivir | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-413 | 62332-0413-10 |
| Oseltamivir | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-414 | 62332-0414-10 |
| Oseltamivir | Oseltamivir phosphate 75 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-415 | 62332-0415-10 |
Other NDCs under ANDA 218565
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 |
|---|---|---|---|---|
| Oseltamiviroseltamivir phosphate | Oseltamivir phosphate 45 mg/1 | CapsuleOral | Laurus Labs Limited | 42385-986 |
| Oseltamiviroseltamivir phosphate | Oseltamivir phosphate 30 mg/1 | CapsuleOral | Laurus Labs Limited | 42385-985 |