Levetiracetam NDC 0378-5615

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-5615Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-5615Add 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
0378-5615-05	00378561505	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5615-05)Marketed from Nov 4, 2008
0378-5615-78	00378561578	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5615-78)Marketed from Nov 4, 2008

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): Levetiracetam
Generic name (nonproprietary): levetiracetam
Active ingredients: Levetiracetam — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076919
Marketing start: Nov 4, 2008
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 0378-5615_8eaa3318-fe96-4d3e-9f49-3286cb04bfbfSPL ID 8eaa3318-fe96-4d3e-9f49-3286cb04bfbfSPL set ID 0a987d59-560f-4650-96ec-31aec81953b5RxCUI 311289, 311290, 387003UNII 44YRR34555

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

N400378561505 followed by a unit qualifier and the quantity

Package 00378-5615-05. 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 12, 2025.

Indications (excerpt from the label)

Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Levetiracetam is indicated for adjunctive therapy for the treatment of: • Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2 ) • Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3 ) 1.1 Partial-Onset Seizures Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam is indicated as adjunctive therapy for the treatment of myoclonic se…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076919

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

FDA NDC Directory listings under ANDA 076919
Product	Strength	Form · route	Labeler	Product NDC
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-5699
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-052
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-821
Levetiracetam	Levetiracetam 750 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-5617
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-0288