Prescription drug · ANDA
LEVETIRACETAM Extended-release (Levetiracetam) NDC 81665-101
Levetiracetam 500 mg/1 · Tablet, Extended release · Oral · Omnivium Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81665-101-12 | 8166501011281665010112 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-101-12)Marketed from May 5, 2023 | |
| 81665-101-60 | 8166501016081665010160 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-101-60)Marketed from May 5, 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 Extended-releaseSuffix: Extended-release
- Generic name (nonproprietary)
- levetiracetam
- Active ingredients
- Levetiracetam — 500 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Omnivium Pharmaceuticals LLCNDC labeler code 81665
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212688
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 81665-101_c50830af-76fa-476a-a88d-50f38f9ecc42SPL ID c50830af-76fa-476a-a88d-50f38f9ecc42SPL set ID 1a31134d-6b63-4d14-8445-0ed132e6c88dRxCUI 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
N481665010112followed by a unit qualifier and the quantityPackage 81665-0101-12. 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.
About NDC 81665-101
- What is NDC 81665-101?
- 81665-101 is the product NDC for LEVETIRACETAM Extended-release (levetiracetam), Levetiracetam 500 mg/1 tablet, extended release, listed with the FDA by Omnivium Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- LEVETIRACETAM Extended-release (Levetiracetam).
- What is the active ingredient?
- Levetiracetam.
- Who is the labeler?
- Omnivium Pharmaceuticals LLC, NDC labeler code 81665. 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 Extended-release?
- 5 other product NDCs are listed under this name. See all LEVETIRACETAM Extended-release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other LEVETIRACETAM Extended-release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Levetiracetam Extended-Releaselevetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-189 | 50228-0189-0550228-0189-3050228-0189-60 |
| Levetiracetam Extended-Releaselevetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-190 | 50228-0190-0550228-0190-3050228-0190-60 |
| LEVETIRACETAM Extended-releaselevetiracetam | Levetiracetam 750 mg/1 | Tablet, Extended releaseOral | Omnivium Pharmaceuticals LLC | 81665-100 | 81665-0100-1281665-0100-60 |
| Levetiracetam Extended-Releaselevetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 60429-349 | 60429-0349-60 |
| Levetiracetam Extended-Releaselevetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 60429-350 | 60429-0350-60 |
Other NDCs under ANDA 212688
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| LEVETIRACETAM Extended-releaselevetiracetam | Levetiracetam 750 mg/1 | Tablet, Extended releaseOral | Omnivium Pharmaceuticals LLC | 81665-100 |