NDC codes

FDA NDC Directory
Product NDC (as listed)69452-412Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69452-0412Add 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 NDC11-digit (billing)PackageCopy
69452-412-886945204128869452041288473 mL in 1 BOTTLE (69452-412-88)Marketed from Jul 18, 2024

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
Bionpharma Inc.NDC labeler code 69452
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079120
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 69452-412_4fae5b8b-e3f2-f9a9-e063-6294a90ab8f3SPL ID 4fae5b8b-e3f2-f9a9-e063-6294a90ab8f3SPL set ID 1d75b15e-881c-a00f-e063-6394a90a4138RxCUI 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

N469452041288 followed by a unit qualifier and the quantity

Package 69452-0412-88. 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 .

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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69452-412

What is NDC 69452-412?
69452-412 is the product NDC for Levetiracetam, Levetiracetam 100 mg/mL solution, listed with the FDA by Bionpharma Inc.. 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?
Bionpharma Inc., NDC labeler code 69452. 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?
260 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-028855154-0288-00
LevetiracetamLevetiracetam 750 mg/1Tablet, Film coated, Extended releaseOralREMEDYREPACK INC.70518-473170518-4731-00
LevetiracetamLevetiracetam 100 mg/mLInjection, Solution, ConcentrateIntravenousBaxter Healthcare Corporation36000-26536000-0265-0536000-0265-10
LevetiracetamLevetiracetam 1000 mg/1TabletOralDirect_Rx72189-67972189-0679-6072189-0679-82
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-04687441-0046-01
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralCoupler LLC67046-042067046-0420-03
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralInjecta Medcial LLC87234-003587234-0035-01
LevetiracetamLevetiracetam 1000 mg/1Tablet, Film coatedOralCoupler LLC67046-086367046-0863-03
LevetiracetamLevetiracetam 500 mg/1TabletOralCoupler LLC67046-209467046-2094-03
LevetiracetamLevetiracetam 250 mg/1Tablet, Film coatedOralCoupler LLC67046-088067046-0880-03

All 261 Levetiracetam NDCs

Other NDCs under ANDA 079120

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

FDA NDC Directory listings under ANDA 079120
ProductStrengthForm · routeLabelerProduct NDC
LevetiracetamLevetiracetam 100 mg/mLSolutionOralKesin Pharma Corporation81033-013

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