Prescription drug · ANDA
Levetiracetam ER (Levetiracetam) NDC 70518-4125
Levetiracetam 500 mg/1 · Tablet, Film coated, Extended release · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4125-0 | 70518412500 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-4125-0)Marketed from Jul 1, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 ERSuffix: ER
- Generic name (nonproprietary)
- levetiracetam
- Active ingredients
- Levetiracetam — 500 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205130
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 70518-4125_5a0a3821-3986-30cf-e063-6394a90a57d0SPL ID 5a0a3821-3986-30cf-e063-6394a90a57d0SPL set ID 2d57f22f-fecc-466e-a444-87708c7c2f80RxCUI 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
N470518412500followed by a unit qualifier and the quantityPackage 70518-4125-00. 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 is 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 70518-4125
- What is NDC 70518-4125?
- 70518-4125 is the product NDC for Levetiracetam ER (levetiracetam), Levetiracetam 500 mg/1 tablet, film coated, extended release, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levetiracetam ER (Levetiracetam).
- What is the active ingredient?
- Levetiracetam.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. 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.
Related NDCs: other Levetiracetam ER 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 ER | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | Direct_Rx | 72189-510 | 72189-0510-60 |
| 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 205130
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 ERlevetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-332 |
| Levetiracetam ERlevetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coated, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-333 |
| Levetiracetam ERlevetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 71205-728 |
| Levetiracetam ERlevetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 71205-880 |
| Levetiracetam ERlevetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 71205-881 |
| Levetiracetam Extended-Releaselevetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-189 |
| Levetiracetam Extended-Releaselevetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-190 |