Prescription drug · NDA
Elepsia XR 1500 Mg (Levetiracetam) NDC 80705-101
Levetiracetam 1500 mg/1 · Tablet, Extended release · Oral · TRIPOINT THERAPEUTICS, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80705-101-02 | 80705010102 | 1 BLISTER PACK in 1 CARTON (80705-101-02) / 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Sep 29, 2021 | |
| 80705-101-30 | 80705010130 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80705-101-30)Marketed from Feb 12, 2021 | |
| 80705-101-99 | 80705010199 | 1 BLISTER PACK in 1 CARTON (80705-101-99) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Feb 12, 2021 |
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)
- Elepsia XR 1500 Mg
- Generic name (nonproprietary)
- levetiracetam
- Active ingredients
- Levetiracetam — 1500 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- TRIPOINT THERAPEUTICS, LLCNDC labeler code 80705
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204417
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 80705-101_3c463bee-1191-4cab-b4d0-367673db19efSPL ID 3c463bee-1191-4cab-b4d0-367673db19efSPL set ID cac83d47-88a2-4447-a0c0-90b44ffda0acRxCUI 1605362, 1605368, 1605372, 1605374UNII 44YRR34555UPC 0380705101302, 0380705100305
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
N480705010102followed by a unit qualifier and the quantityPackage 80705-0101-02. 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)
ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older. ELEPSIA XR is indicated as adjunctive therapy 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 80705-101
- What is NDC 80705-101?
- 80705-101 is the product NDC for Elepsia XR 1500 Mg (levetiracetam), Levetiracetam 1500 mg/1 tablet, extended release, listed with the FDA by TRIPOINT THERAPEUTICS, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Elepsia XR 1500 Mg (Levetiracetam).
- What is the active ingredient?
- Levetiracetam.
- Who is the labeler?
- TRIPOINT THERAPEUTICS, LLC, NDC labeler code 80705. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Elepsia XR 1500 Mg?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 204417
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 |
|---|---|---|---|---|
| Elepsia XR 1000 Mglevetiracetam | Levetiracetam 1000 mg/1 | Tablet, Extended releaseOral | TRIPOINT THERAPEUTICS, LLC | 80705-100 |