LEVETIRACETAM Extended-release NDC 81665-101

NDC codes

FDA NDC Directory

Product NDC (as listed)81665-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81665-0101Add 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
81665-101-12	81665010112	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-101-12)Marketed from May 5, 2023
81665-101-60	81665010160	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-101-60)Marketed from May 5, 2023

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): LEVETIRACETAM Extended-releaseSuffix: Extended-release
Generic name (nonproprietary): levetiracetam
Active ingredients: Levetiracetam — 500 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Omnivium Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212688
Marketing start: May 5, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 81665-101_c50830af-76fa-476a-a88d-50f38f9ecc42SPL ID c50830af-76fa-476a-a88d-50f38f9ecc42SPL set ID 1a31134d-6b63-4d14-8445-0ed132e6c88dRxCUI 807832, 846378UNII 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

N481665010112 followed by a unit qualifier and the quantity

Package 81665-0101-12. 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, 2026.

Indications (excerpt from the label)

Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older. Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212688

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

FDA NDC Directory listings under ANDA 212688
Product	Strength	Form · route	Labeler	Product NDC
LEVETIRACETAM Extended-releaselevetiracetam	Levetiracetam 750 mg/1	Tablet, Extended releaseOral	Omnivium Pharmaceuticals LLC	81665-100

LEVETIRACETAM Extended-release (levetiracetam) NDC 81665-101