What is NDC 43547-346?

43547-346 is the product NDC for Levetiracetam, Levetiracetam 750 mg/1 tablet, film coated, extended release, listed with the FDA by Solco healthcare U.S., LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Solco healthcare U.S., LLC, NDC labeler code 43547. 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 43547-346 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-346Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0346Add 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
43547-346-06	43547034606	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-346-06)Marketed from May 1, 2014
43547-346-50	43547034650	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-346-50)Marketed from May 1, 2014

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 — 750 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Solco healthcare U.S., LLCNDC labeler code 43547
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203468
Marketing start: May 1, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 43547-346_801f853c-1f42-4d65-ae2d-2bace0d5f3f8SPL ID 801f853c-1f42-4d65-ae2d-2bace0d5f3f8SPL set ID bc8644ed-3320-47b5-adf3-8b972bea8abdRxCUI 807832, 846378UNII 44YRR34555UPC 0343547346065, 0343547345068

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

N443547034606 followed by a unit qualifier and the quantity

Package 43547-0346-06. 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 Mar 28, 2024.

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)

About NDC 43547-346

What is NDC 43547-346?: 43547-346 is the product NDC for Levetiracetam, Levetiracetam 750 mg/1 tablet, film coated, extended release, listed with the FDA by Solco healthcare U.S., LLC. 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?: Solco healthcare U.S., LLC, NDC labeler code 43547. 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 203468

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

FDA NDC Directory listings under ANDA 203468
Product	Strength	Form · route	Labeler	Product NDC
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coated, Extended releaseOral	Solco healthcare U.S., LLC	43547-345
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	63629-9847
Levetiracetam	Levetiracetam 500 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-4005
Levetiracetam	Levetiracetam 750 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-4731
Levetiracetam ER	Levetiracetam 500 mg/1	Tablet, Film coated, Extended releaseOral	Direct_Rx	72189-510