NDC codes

FDA NDC Directory
Product NDC (as listed)76494-530Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76494-0530Add 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
76494-530-1276494053012120 TABLET, FILM COATED in 1 BOTTLE (76494-530-12)Marketed from Sep 11, 2012

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 — 750 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Prinston Pharmaceutical Inc.NDC labeler code 76494
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078106
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 76494-530_bf716ab6-d438-4a19-8193-dbc05b4eabadSPL ID bf716ab6-d438-4a19-8193-dbc05b4eabadSPL set ID d818ef84-9b3e-434b-92d9-910cfa8af7daRxCUI 311288, 311289, 311290, 387003UNII 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

N476494053012 followed by a unit qualifier and the quantity

Package 76494-0530-12. 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 an antiepileptic drug indicated for adjunctive therapy in the treatment of: • Partial onset seizures in patients four years of age and older with epilepsy ( 1.1 ) • 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 is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children four years of age and older with epilepsy. Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76494-530

What is NDC 76494-530?
76494-530 is the product NDC for Levetiracetam, Levetiracetam 750 mg/1 tablet, film coated, listed with the FDA by Prinston Pharmaceutical 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?
Prinston Pharmaceutical Inc., NDC labeler code 76494. 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
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 262 Levetiracetam NDCs

Other NDCs under ANDA 078106

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

FDA NDC Directory listings under ANDA 078106
ProductStrengthForm · routeLabelerProduct NDC
LevetiracetamLevetiracetam 250 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-221
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-222
LevetiracetamLevetiracetam 750 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-223
LevetiracetamLevetiracetam 1000 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-224
LevetiracetamLevetiracetam 250 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-880
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-881
LevetiracetamLevetiracetam 750 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-882
LevetiracetamLevetiracetam 1000 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-883
LevetiracetamLevetiracetam 1000 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-7516
LevetiracetamLevetiracetam 250 mg/1Tablet, Film coatedOralPrinston Pharmaceutical Inc.76494-528
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralPrinston Pharmaceutical Inc.76494-529
LevetiracetamLevetiracetam 1000 mg/1Tablet, Film coatedOralPrinston Pharmaceutical Inc.76494-531

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