Etoposide NDC 0378-3266

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-3266Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-3266Add 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 NDC	11-digit (billing)	Package	Copy
0378-3266-94	00378326694	20 CAPSULE in 1 CARTON (0378-3266-94)Marketed from Oct 22, 2001

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Etoposide
Generic name (nonproprietary): etoposide
Active ingredients: Etoposide — 50 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075635
Marketing start: Oct 22, 2001
Listing expires: Dec 31, 2026
Other FDA classes: Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 0378-3266_a591eea6-af04-4207-b0f7-61fbada4719cSPL ID a591eea6-af04-4207-b0f7-61fbada4719cSPL set ID 508a418e-985f-4208-9324-2230655bb5c2RxCUI 197687UNII 6PLQ3CP4P3
Pharmacologic class: Topoisomerase 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

N400378326694 followed by a unit qualifier and the quantity

Package 00378-3266-94. 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 Apr 19, 2016. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Etoposide capsules are indicated in the management of the following neoplasms: Small Cell Lung Cancer Etoposide capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)