Levetiracetam NDC 16714-358

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-358Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0358Add 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
16714-358-01	16714035801	473 mL in 1 BOTTLE, PLASTIC (16714-358-01)Marketed from Jan 15, 2009

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
Generic name (nonproprietary): levetiracetam
Active ingredients: Levetiracetam — 100 mg/mL
Dosage form: Solution
Route: Oral
Labeler: NorthStar Rx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079063
Marketing start: Jan 15, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 16714-358_07969bad-3551-432a-b762-06625a68342aSPL ID 07969bad-3551-432a-b762-06625a68342aSPL set ID 483a42b9-c8f3-4f8b-98be-fcac5ab23c7cRxCUI 403884UNII 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

N416714035801 followed by a unit qualifier and the quantity

Package 16714-0358-01. 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 Oct 14, 2024.

Indications (excerpt from the label)

Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Levetiracetam oral solution 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 oral solution 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 oral solution is indicated as adju…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 079063

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

FDA NDC Directory listings under ANDA 079063
Product	Strength	Form · route	Labeler	Product NDC
Levetiracetam	Levetiracetam 100 mg/mL	SolutionOral	REMEDYREPACK INC.	70518-3803
Levetiracetam	Levetiracetam 100 mg/mL	SolutionOral	REMEDYREPACK INC.	70518-3804
Levetiracetam	Levetiracetam 100 mg/mL	SolutionOral	Aurobindo Pharma Limited	65862-250