Prescription drug · ANDA
Levetiracetam Extended-Release (Levetiracetam) NDC 50228-190
Levetiracetam 750 mg/1 · Tablet, Film coated, Extended release · Oral · ScieGen Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-190-05 | 5022801900550228019005 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-190-05)Marketed from Nov 27, 2020 | |
| 50228-190-30 | 5022801903050228019030 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-190-30)Marketed from Nov 27, 2020 | |
| 50228-190-60 | 5022801906050228019060 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-190-60)Marketed from Nov 27, 2020 |
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 — 750 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals, IncNDC labeler code 50228
- 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 50228-190_1d0dd4a0-35e6-418b-e063-6394a90a8b2bSPL ID 1d0dd4a0-35e6-418b-e063-6394a90a8b2bSPL set ID 3e32f341-9926-47a3-a942-d8b9bfa7a55bRxCUI 807832, 846378UNII 44YRR34555UPC 0350228190602, 0350228189606
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
N450228019005followed by a unit qualifier and the quantityPackage 50228-0190-05. 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 50228-190
- What is NDC 50228-190?
- 50228-190 is the product NDC for Levetiracetam Extended-Release (levetiracetam), Levetiracetam 750 mg/1 tablet, film coated, extended release, listed with the FDA by ScieGen Pharmaceuticals, Inc. It has 3 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?
- ScieGen Pharmaceuticals, Inc, NDC labeler code 50228. 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, Extended releaseOral | Omnivium Pharmaceuticals LLC | 81665-101 | 81665-0101-1281665-0101-60 |
| 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, 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 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 | REMEDYREPACK INC. | 70518-4125 |
| 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 |