Prescription drug · ANDA
Levetiracetam NDC 43547-880
Levetiracetam 250 mg/1 · Tablet, Film coated · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-880-15 | 43547088015 | 120 TABLET, FILM COATED in 1 BOTTLE (43547-880-15)Marketed from Sep 1, 2024 | |
| 43547-880-50 | 43547088050 | 500 TABLET, FILM COATED in 1 BOTTLE (43547-880-50)Marketed from Sep 1, 2024 |
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
- Generic name (nonproprietary)
- levetiracetam
- Active ingredients
- Levetiracetam — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Solco Healthcare US, LLCNDC labeler code 43547
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078106
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 43547-880_57f09129-7151-4a75-9d73-9dd32f74ba43SPL ID 57f09129-7151-4a75-9d73-9dd32f74ba43SPL set ID 57f09129-7151-4a75-9d73-9dd32f74ba43RxCUI 311288, 311289, 311290, 387003UNII 44YRR34555UPC 0343547882150, 0343547881153, 0343547883065, 0343547880156
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
N443547088015followed by a unit qualifier and the quantityPackage 43547-0880-15. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 43547-880
- What is NDC 43547-880?
- 43547-880 is the product NDC for Levetiracetam, Levetiracetam 250 mg/1 tablet, film coated, listed with the FDA by Solco Healthcare US, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levetiracetam.
- What is the active ingredient?
- Levetiracetam.
- Who is the labeler?
- Solco Healthcare US, LLC, NDC labeler code 43547. 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?
- 261 other product NDCs are listed under this name. See all Levetiracetam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Levetiracetam 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 | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0288 | 55154-0288-00 |
| Levetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4731 | 70518-4731-00 |
| Levetiracetam | Levetiracetam 100 mg/mL | Injection, Solution, ConcentrateIntravenous | Baxter Healthcare Corporation | 36000-265 | 36000-0265-0536000-0265-10 |
| Levetiracetam | Levetiracetam 1000 mg/1 | TabletOral | Direct_Rx | 72189-679 | 72189-0679-6072189-0679-82 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-046 | 87441-0046-01 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0420 | 67046-0420-03 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Injecta Medcial LLC | 87234-0035 | 87234-0035-01 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0863 | 67046-0863-03 |
| Levetiracetam | Levetiracetam 500 mg/1 | TabletOral | Coupler LLC | 67046-2094 | 67046-2094-03 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0880 | 67046-0880-03 |
Other NDCs under ANDA 078106
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 | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-221 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-222 |
| Levetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-223 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-224 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-881 |
| Levetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-882 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-883 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-7516 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | Prinston Pharmaceutical Inc. | 76494-528 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Prinston Pharmaceutical Inc. | 76494-529 |
| Levetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | Prinston Pharmaceutical Inc. | 76494-530 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | Prinston Pharmaceutical Inc. | 76494-531 |