NDC codes

FDA NDC Directory
Product NDC (as listed)42385-986Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42385-0986Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
42385-986-0142385098601100 CAPSULE in 1 BOTTLE (42385-986-01)Marketed from May 2, 2024
42385-986-11423850986111 BLISTER PACK in 1 CARTON (42385-986-11) / 10 CAPSULE in 1 BLISTER PACK (42385-986-10)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 phosphate45 mg/1
Dosage form
Capsule
Route
Oral
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 42385-986_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

N442385098601 followed by a unit qualifier and the quantity

Package 42385-0986-01. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218565

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 218565
ProductStrengthForm · routeLabelerProduct NDC
Oseltamiviroseltamivir phosphateOseltamivir phosphate 30 mg/1CapsuleOralLaurus Labs Limited42385-985
Oseltamiviroseltamivir phosphateOseltamivir phosphate 75 mg/1CapsuleOralLaurus Labs Limited42385-987

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