Prescription drug · ANDA

Levetiracetam NDC 68001-403

Levetiracetam 500 mg/1 · Tablet, Film coated · Oral · BluePoint Laboratories

NDC codes

FDA NDC Directory
Product NDC (as listed)68001-403Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68001-0403Add 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
68001-403-0368001040303500 TABLET, FILM COATED in 1 BOTTLE (68001-403-03)Marketed from Jun 19, 2019
68001-403-0768001040307120 TABLET, FILM COATED in 1 BOTTLE (68001-403-07)Marketed from Jun 19, 2019

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, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078993
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 68001-403_28d8b606-37b2-642c-e063-6294a90ad080SPL ID 28d8b606-37b2-642c-e063-6294a90ad080SPL set ID 8b74b8bc-d95c-4471-8f74-c3117243bf89RxCUI 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

N468001040303 followed by a unit qualifier and the quantity

Package 68001-0403-03. 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 of my…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078993

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

FDA NDC Directory listings under ANDA 078993
ProductStrengthForm · routeLabelerProduct NDC
LevetiracetamLevetiracetam 750 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-404
LevetiracetamLevetiracetam 250 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-402
LevetiracetamLevetiracetam 1000 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-405
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-3367
LevetiracetamLevetiracetam 250 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-245
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralCoupler LLC67046-0420
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-246
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-046
LevetiracetamLevetiracetam 750 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-247
LevetiracetamLevetiracetam 250 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-4171
LevetiracetamLevetiracetam 1000 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-315
LevetiracetamLevetiracetam 250 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7123
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7124
LevetiracetamLevetiracetam 750 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7125
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-657
LevetiracetamLevetiracetam 1000 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-668
LevetiracetamLevetiracetam 250 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-859
LevetiracetamLevetiracetam 750 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-882
LevetiracetamLevetiracetam 1000 mg/1Tablet, Film coatedOralCoupler LLC67046-0863
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7768

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