NDC codes

FDA NDC Directory
Product NDC (as listed)13668-014Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13668-0014Add 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
13668-014-051366800140513668001405500 TABLET in 1 BOTTLE (13668-014-05)Marketed from Jan 15, 2009
13668-014-121366800141213668001412120 TABLET in 1 BOTTLE (13668-014-12)Marketed from Jan 15, 2009
13668-014-251366800142513668001425250 TABLET in 1 BOTTLE (13668-014-25)Marketed from Jan 15, 2009
13668-014-3113668001431136680014312500 TABLET in 1 BOTTLE (13668-014-31)Marketed from Jan 15, 2009
13668-014-60136680014601366800146060 TABLET in 1 BOTTLE (13668-014-60)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 — 250 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Torrent Pharmaceuticals LimitedNDC labeler code 13668
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 13668-014_b8792837-f86a-4e67-b1a5-ec8ca278fe77SPL ID b8792837-f86a-4e67-b1a5-ec8ca278fe77SPL set ID 6ab24168-058d-496e-9023-da8ee6353eb3RxCUI 311288, 311289, 311290, 387003UNII 44YRR34555UPC 0313668017601, 0313668016604, 0313668014600, 0313668015607

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

N413668001405 followed by a unit qualifier and the quantity

Package 13668-0014-05. 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 is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) 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 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 Levetiracetam tablets are indicated as adjunctive therapy for the treatment o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 13668-014

What is NDC 13668-014?
13668-014 is the product NDC for Levetiracetam, Levetiracetam 250 mg/1 tablet, listed with the FDA by Torrent Pharmaceuticals Limited. It has 5 package NDCs, 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?
Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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?
268 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 coatedOralREMEDYREPACK INC.70518-479270518-4792-00
LevetiracetamLevetiracetam 250 mg/1Tablet, Film coatedOralDirect_Rx72189-69672189-0696-30
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 500 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-04687441-0046-01
LevetiracetamLevetiracetam 1000 mg/1TabletOralDirect_Rx72189-67972189-0679-6072189-0679-82
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

All 269 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 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 500 mg/1TabletOralOWP Pharmaceuticals, Inc.69102-105
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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