NDC codes

FDA NDC Directory
Product NDC (as listed)69102-105Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69102-0105Add 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
69102-105-016910201050169102010501120 TABLET in 1 BOTTLE (69102-105-01)Marketed from Oct 28, 2020

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 — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
OWP Pharmaceuticals, Inc.NDC labeler code 69102
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078858
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 69102-105_c7262ce0-c186-487b-9808-b340d31d8fe4SPL ID c7262ce0-c186-487b-9808-b340d31d8fe4SPL set ID e662bf5b-c81c-4bcd-ba2e-552df95ca6f9RxCUI 311288, 311289, 311290, 387003, 1875868UNII 44YRR34555UPC 0369102107018, 0369102106011

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

N469102010501 followed by a unit qualifier and the quantity

Package 69102-0105-01. 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 .

Indications (excerpt from the label)

Roweepra (levetiracetam) is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Roweepra (levetiracetam) 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 Roweepra (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 Roweepra (levetiracetam) tablets are indicat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69102-105

What is NDC 69102-105?
69102-105 is the product NDC for Levetiracetam, Levetiracetam 500 mg/1 tablet, listed with the FDA by OWP Pharmaceuticals, 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?
OWP Pharmaceuticals, Inc., NDC labeler code 69102. 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 078858

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

FDA NDC Directory listings under ANDA 078858
ProductStrengthForm · routeLabelerProduct NDC
LevetiracetamLevetiracetam 250 mg/1TabletOralTorrent Pharmaceuticals Limited13668-014
LevetiracetamLevetiracetam 500 mg/1TabletOralTorrent Pharmaceuticals Limited13668-015
LevetiracetamLevetiracetam 750 mg/1TabletOralTorrent Pharmaceuticals Limited13668-016
LevetiracetamLevetiracetam 1000 mg/1TabletOralTorrent Pharmaceuticals Limited13668-017
LevetiracetamLevetiracetam 500 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-499
LevetiracetamLevetiracetam 750 mg/1TabletOralOWP Pharmaceuticals, Inc.69102-106
LevetiracetamLevetiracetam 1000 mg/1TabletOralOWP Pharmaceuticals, Inc.69102-107
LevetiracetamLevetiracetam 500 mg/1TabletOralBryant Ranch Prepack71335-2282
RoweepralevetiracetamLevetiracetam 250 mg/1TabletOralOWP Pharmaceuticals, Inc.69102-108

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