NDC codes

FDA NDC Directory
Product NDC (as listed)65862-250Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0250Add 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
65862-250-056586202500565862025005500 mL in 1 BOTTLE, PLASTIC (65862-250-05)Marketed from Jan 15, 2009
65862-250-476586202504765862025047473 mL in 1 BOTTLE, PLASTIC (65862-250-47)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 — 100 mg/mL
Dosage form
Solution
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079063
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 65862-250_30506f3f-c853-45db-99dc-059d1dc76cd9SPL ID 30506f3f-c853-45db-99dc-059d1dc76cd9

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

N465862025005 followed by a unit qualifier and the quantity

Package 65862-0250-05. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 65862-250

What is NDC 65862-250?
65862-250 is the product NDC for Levetiracetam, Levetiracetam 100 mg/mL solution, listed with the FDA by Aurobindo Pharma Limited. It has 2 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?
Aurobindo Pharma Limited, NDC labeler code 65862. 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 079063

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

FDA NDC Directory listings under ANDA 079063
ProductStrengthForm · routeLabelerProduct NDC
LevetiracetamLevetiracetam 100 mg/mLSolutionOralNorthStar Rx LLC16714-358
LevetiracetamLevetiracetam 100 mg/mLSolutionOralREMEDYREPACK INC.70518-3803
LevetiracetamLevetiracetam 100 mg/mLSolutionOralREMEDYREPACK INC.70518-3804

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