What is NDC 63323-400?

63323-400 is the product NDC for Levetiracetam, Levetiracetam 100 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 63323. 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?

261 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 63323-400 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-400Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0400Add 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
63323-400-44	63323040044	10 VIAL, SINGLE-USE in 1 TRAY (63323-400-44) / 5 mL in 1 VIAL, SINGLE-USE (63323-400-41)Marketed from Aug 13, 2015

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: Injection, Solution
Route: Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090876
Marketing start: Aug 13, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 63323-400_87d6e0ef-ffd5-49d6-b9df-ef216576d3e8SPL ID 87d6e0ef-ffd5-49d6-b9df-ef216576d3e8SPL set ID cc4a06f1-6509-4650-b20c-259a39353733RxCUI 647121UNII 44YRR34555UPC 0363323400415

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N463323040044 followed by a unit qualifier and the quantity

Package 63323-0400-44. 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 Feb 28, 2022.

Indications (excerpt from the label)

Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Levetiracetam injection 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 ) Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible ( 1.4 ) 1.1 Partial-Onset Seizures Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 mont…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-400

What is NDC 63323-400?: 63323-400 is the product NDC for Levetiracetam, Levetiracetam 100 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. 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?: Fresenius Kabi USA, LLC, NDC labeler code 63323. 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?: 261 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 1000 mg/1	TabletOral	Direct_Rx	72189-679	72189-0679-6072189-0679-82
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-046	87441-0046-01
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 262 Levetiracetam NDCs