What is NDC 0378-3266?

0378-3266 is the product NDC for Etoposide, Etoposide 50 mg/1 capsule, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Etoposide?

13 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Etoposide NDC 0378-3266 | National Drug Code

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	0037832669400378326694	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.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075635
Marketing start: Oct 22, 2001
Listing expires: Dec 31, 2027
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)

About NDC 0378-3266

What is NDC 0378-3266?: 0378-3266 is the product NDC for Etoposide, Etoposide 50 mg/1 capsule, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Etoposide.
What is the active ingredient?: Etoposide.
Who is the labeler?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Etoposide?: 13 other product NDCs are listed under this name. See all Etoposide NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Etoposide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Etoposide	Etoposide 20 mg/mL	Injection, Solution, ConcentrateIntravenous	BluePoint Laboratories	68001-681	68001-0681-25
Etoposide	Etoposide 20 mg/mL	Injection, Solution, ConcentrateIntravenous	BluePoint Laboratories	68001-682	68001-0682-26
Etoposide	Etoposide 20 mg/mL	Injection, Solution, ConcentrateIntravenous	BluePoint Laboratories	68001-683	68001-0683-27
Etoposide	Etoposide 20 mg/mL	Injection, Solution, ConcentrateIntravenous	Meitheal Pharmaceuticals Inc.	71288-175	71288-0175-05
Etoposide	Etoposide 20 mg/mL	Injection, Solution, ConcentrateIntravenous	Meitheal Pharmaceuticals Inc.	71288-176	71288-0176-25
Etoposide	Etoposide 20 mg/mL	Injection, Solution, ConcentrateIntravenous	Meitheal Pharmaceuticals Inc.	71288-177	71288-0177-50
Etoposide	Etoposide 20 mg/mL	InjectionIntravenous	Accord Healthcare Inc.	16729-114	16729-0114-0816729-0114-1116729-0114-31
Etoposide	Etoposide 20 mg/mL	InjectionIntravenous	BluePoint Laboratories	68001-265	68001-0265-2568001-0265-2668001-0265-27
Etoposide	Etoposide 20 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	63323-104	63323-0104-0563323-0104-0663323-0104-25+1 more
Etoposide	Etoposide 20 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9511	00143-9511-01

All 14 Etoposide NDCs