What is NDC 65162-539?

65162-539 is the product NDC for Levetiracetam, Levetiracetam 1000 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 65162-539 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-539Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0539Add 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
65162-539-06	65162053906	60 TABLET, FILM COATED in 1 BOTTLE (65162-539-06)Marketed from Feb 28, 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
Generic name (nonproprietary): levetiracetam
Active ingredients: Levetiracetam — 1000 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090767
Marketing start: Feb 28, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 65162-539_3a499e5a-b4c5-46b8-b667-ee79134e488aSPL ID 3a499e5a-b4c5-46b8-b667-ee79134e488aSPL set ID d7932a2c-a3b7-46df-a306-1f17716160a0RxCUI 311288, 311289, 311290, 387003UNII 44YRR34555UPC 0365162528169, 0365162529166, 0365162538168, 0365162539066

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

N465162053906 followed by a unit qualifier and the quantity

Package 65162-0539-06. 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 Nov 28, 2017.

Indications (excerpt from the label)

Levetiracetam tablets are indicated for adjunctive therapy in the 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 are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam tablets are indicated as adjunctive therapy in …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65162-539

What is NDC 65162-539?: 65162-539 is the product NDC for Levetiracetam, Levetiracetam 1000 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals LLC. 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?: Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 090767

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

FDA NDC Directory listings under ANDA 090767
Product	Strength	Form · route	Labeler	Product NDC
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7717
Levetiracetam	Levetiracetam 250 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	64980-604
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	64980-605
Levetiracetam	Levetiracetam 750 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	64980-606
Levetiracetam	Levetiracetam 1000 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	64980-607
Levetiracetam	Levetiracetam 250 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-528
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-529
Levetiracetam	Levetiracetam 750 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-538