What is NDC 0615-8498?

0615-8498 is the product NDC for Levetiracetam, Levetiracetam 250 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Levetiracetam?

266 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Levetiracetam NDC 0615-8498 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8498Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8498Add 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
0615-8498-39	00615849839	30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8498-39)Marketed from Jan 10, 2024

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 — 250 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214815
Marketing start: Oct 7, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 0615-8498_8d4105d5-1eda-42d1-b232-34b8b189e63aSPL ID 8d4105d5-1eda-42d1-b232-34b8b189e63aSPL set ID dfb7c640-623e-43d1-8ee8-479dccd53d0aRxCUI 311288, 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

N400615849839 followed by a unit qualifier and the quantity

Package 00615-8498-39. 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 Jan 16, 2025.

Indications (excerpt from the label)

Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Levetiracetam tablets are 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 tablets are 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 tablets are indicated as adjunctive thera…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8498

What is NDC 0615-8498?: 0615-8498 is the product NDC for Levetiracetam, Levetiracetam 250 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Levetiracetam.
What is the active ingredient?: Levetiracetam.
Who is the labeler?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Levetiracetam?: 266 other product NDCs are listed under this name. See all Levetiracetam 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 Levetiracetam NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-0288	55154-0288-00
Levetiracetam	Levetiracetam 750 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-4731	70518-4731-00
Levetiracetam	Levetiracetam 100 mg/mL	Injection, Solution, ConcentrateIntravenous	Baxter Healthcare Corporation	36000-265	36000-0265-0536000-0265-10
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-046	87441-0046-01
Levetiracetam	Levetiracetam 1000 mg/1	TabletOral	Direct_Rx	72189-679	72189-0679-6072189-0679-82
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0420	67046-0420-03
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Injecta Medcial LLC	87234-0035	87234-0035-01
Levetiracetam	Levetiracetam 1000 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0863	67046-0863-03
Levetiracetam	Levetiracetam 500 mg/1	TabletOral	Coupler LLC	67046-2094	67046-2094-03
Levetiracetam	Levetiracetam 250 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0880	67046-0880-03

All 267 Levetiracetam NDCs

Other NDCs under ANDA 214815

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

FDA NDC Directory listings under ANDA 214815
Product	Strength	Form · route	Labeler	Product NDC
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-095
Levetiracetam	Levetiracetam 250 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-094
Levetiracetam	Levetiracetam 750 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-096
Levetiracetam	Levetiracetam 1000 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-097
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8499
Levetiracetam	Levetiracetam 750 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8500
Levetiracetam	Levetiracetam 1000 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8501