NDC codes

FDA NDC Directory
Product NDC (as listed)43063-617Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0617Add 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
43063-617-604306306176060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-617-60)Marketed from Aug 1, 2015

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
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078154
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 43063-617_53c43c71-6030-5313-e063-6294a90a3108SPL ID 53c43c71-6030-5313-e063-6294a90a3108SPL set ID c4b2da6a-ed50-4a54-90bd-32f76b178736RxCUI 311289UNII 44YRR34555UPC 0343063617601

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

N443063061760 followed by a unit qualifier and the quantity

Package 43063-0617-60. 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 tablets USP are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam tablets USP are indicated for adjunctive therapy for treatment of: Partial onset seizures in patients one month 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 tablets USP are indicated for treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with J…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43063-617

What is NDC 43063-617?
43063-617 is the product NDC for Levetiracetam, Levetiracetam 500 mg/1 tablet, film coated, listed with the FDA by PD-Rx 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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 078154

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

FDA NDC Directory listings under ANDA 078154
ProductStrengthForm · routeLabelerProduct NDC
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralProficient Rx LP63187-360
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-4137
LevetiracetamLevetiracetam 250 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-4675
LevetiracetamLevetiracetam 250 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-112
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-113
LevetiracetamLevetiracetam 750 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-114
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-8254
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1108
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1772
LevetiracetamLevetiracetam 750 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2098

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