What is NDC 76494-531?

76494-531 is the product NDC for Levetiracetam, Levetiracetam 1000 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.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Levetiracetam NDC 76494-531 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76494-531Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76494-0531Add 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 NDC	11-digit (billing)	Package	Copy
76494-531-06	76494053106	60 TABLET, FILM COATED in 1 BOTTLE (76494-531-06)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 — 1000 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: Sep 11, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 76494-531_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

N476494053106 followed by a unit qualifier and the quantity

Package 76494-0531-06. 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 Aug 1, 2020.

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 76494-531

What is NDC 76494-531?: 76494-531 is the product NDC for Levetiracetam, Levetiracetam 1000 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-0288	55154-0288-00
Levetiracetam	Levetiracetam 750 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-4731	70518-4731-00
Levetiracetam	Levetiracetam 100 mg/mL	Injection, Solution, ConcentrateIntravenous	Baxter Healthcare Corporation	36000-265	36000-0265-0536000-0265-10
Levetiracetam	Levetiracetam 1000 mg/1	TabletOral	Direct_Rx	72189-679	72189-0679-6072189-0679-82
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-046	87441-0046-01
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0420	67046-0420-03
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Injecta Medcial LLC	87234-0035	87234-0035-01
Levetiracetam	Levetiracetam 1000 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0863	67046-0863-03
Levetiracetam	Levetiracetam 500 mg/1	TabletOral	Coupler LLC	67046-2094	67046-2094-03
Levetiracetam	Levetiracetam 250 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0880	67046-0880-03

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
Product	Strength	Form · route	Labeler	Product NDC
Levetiracetam	Levetiracetam 250 mg/1	Tablet, Film coatedOral	Solco Healthcare US, LLC	43547-221
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Solco Healthcare US, LLC	43547-222
Levetiracetam	Levetiracetam 750 mg/1	Tablet, Film coatedOral	Solco Healthcare US, LLC	43547-223
Levetiracetam	Levetiracetam 1000 mg/1	Tablet, Film coatedOral	Solco Healthcare US, LLC	43547-224
Levetiracetam	Levetiracetam 250 mg/1	Tablet, Film coatedOral	Solco Healthcare US, LLC	43547-880
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Solco Healthcare US, LLC	43547-881
Levetiracetam	Levetiracetam 750 mg/1	Tablet, Film coatedOral	Solco Healthcare US, LLC	43547-882
Levetiracetam	Levetiracetam 1000 mg/1	Tablet, Film coatedOral	Solco Healthcare US, LLC	43547-883
Levetiracetam	Levetiracetam 1000 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-7516
Levetiracetam	Levetiracetam 250 mg/1	Tablet, Film coatedOral	Prinston Pharmaceutical Inc.	76494-528
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Prinston Pharmaceutical Inc.	76494-529
Levetiracetam	Levetiracetam 750 mg/1	Tablet, Film coatedOral	Prinston Pharmaceutical Inc.	76494-530