What is NDC 72189-510?

72189-510 is the product NDC for Levetiracetam ER, Levetiracetam 500 mg/1 tablet, film coated, extended release, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. 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 ER?

6 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Levetiracetam ER NDC 72189-510 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-510Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0510Add 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
72189-510-60	72189051060	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72189-510-60)Marketed from Aug 25, 2023

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 ER
Generic name (nonproprietary): levetiracetam er
Active ingredients: Levetiracetam — 500 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203468
Marketing start: Aug 25, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 72189-510_2c4e5941-7089-8be7-e063-6394a90a92e3SPL ID 2c4e5941-7089-8be7-e063-6394a90a92e3SPL set ID 03c449a1-9b40-a7da-e063-6394a90a984eRxCUI 807832UNII 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

N472189051060 followed by a unit qualifier and the quantity

Package 72189-0510-60. 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 Jan 22, 2025.

Indications (excerpt from the label)

Levetiracetam extended-release tablets are indicated for the treatment of partial-onset in patients 12 years of age and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-510

What is NDC 72189-510?: 72189-510 is the product NDC for Levetiracetam ER, Levetiracetam 500 mg/1 tablet, film coated, extended release, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Levetiracetam ER.
What is the active ingredient?: Levetiracetam.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. 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 ER?: 6 other product NDCs are listed under this name. See all Levetiracetam ER 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 ER NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Levetiracetam ERlevetiracetam	Levetiracetam 500 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-4125	70518-4125-00
Levetiracetam ERlevetiracetam	Levetiracetam 500 mg/1	Tablet, Film coated, Extended releaseOral	Westminster Pharmaceuticals, LLC	69367-332	69367-0332-60
Levetiracetam ERlevetiracetam	Levetiracetam 750 mg/1	Tablet, Film coated, Extended releaseOral	Westminster Pharmaceuticals, LLC	69367-333	69367-0333-60
Levetiracetam ERlevetiracetam	Levetiracetam 500 mg/1	Tablet, Film coated, Extended releaseOral	Proficient Rx LP	71205-728	71205-0728-3071205-0728-6071205-0728-90
Levetiracetam ERlevetiracetam	Levetiracetam 500 mg/1	Tablet, Film coated, Extended releaseOral	Proficient Rx LP	71205-880	71205-0880-0071205-0880-1171205-0880-30+6 more
Levetiracetam ERlevetiracetam	Levetiracetam 750 mg/1	Tablet, Film coated, Extended releaseOral	Proficient Rx LP	71205-881	71205-0881-0071205-0881-1171205-0881-30+6 more

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 750 mg/1	Tablet, Film coated, Extended releaseOral	Solco healthcare U.S., LLC	43547-346
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