NDC codes

FDA NDC Directory
Product NDC (as listed)60429-350Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60429-0350Add 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
60429-350-606042903506060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60429-350-60)Marketed from Mar 5, 2013

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 Extended-ReleaseSuffix: Extended-Release
Generic name (nonproprietary)
levetiracetam
Active ingredients
Levetiracetam750 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091261
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 60429-350_445d08d0-1f31-1ac0-e063-6394a90a2cddSPL ID 445d08d0-1f31-1ac0-e063-6394a90a2cddSPL set ID 5dde1889-a217-4493-9a71-9fd39ed04630RxCUI 807832, 846378UNII 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

N460429035060 followed by a unit qualifier and the quantity

Package 60429-0350-60. 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 extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older. Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091261

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

FDA NDC Directory listings under ANDA 091261
ProductStrengthForm · routeLabelerProduct NDC
LevetiracetamLevetiracetam 500 mg/1Tablet, Film coated, Extended releaseOralApotex Corp.60505-3280
LevetiracetamLevetiracetam 750 mg/1Tablet, Film coated, Extended releaseOralApotex Corp.60505-3517
Levetiracetam Extended-ReleaselevetiracetamLevetiracetam 500 mg/1Tablet, Film coated, Extended releaseOralGolden State Medical Supply, Inc.60429-349

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