Prescription drug · ANDA
Levetiracetam NDC 43547-221
Levetiracetam 250 mg/1 · Tablet, Film coated · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-221-15 | 43547022115 | 120 TABLET, FILM COATED in 1 BOTTLE (43547-221-15)Marketed from Sep 11, 2012 |
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 43547-221_da6c3e56-5044-4f0b-9f0e-7267e2fe89bcSPL ID da6c3e56-5044-4f0b-9f0e-7267e2fe89bcSPL set ID dd713e60-478c-43cd-b680-ff594a0b3864RxCUI 311288, 311289, 311290, 387003UNII 44YRR34555UPC 0343547223151, 0343547222154, 0343547224066, 0343547221157
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
N443547022115followed by a unit qualifier and the quantityPackage 43547-0221-15. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Levetiracetam is indicated for adjunctive therapy for the treatment of: • Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2 ) • Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3 ) 1.1 Partial-Onset Seizures Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam is indicated as adjunctive therapy for the treatment of myoclonic se…
Excerpt only. Read the full label for complete information.
About NDC 43547-221
- What is NDC 43547-221?
- 43547-221 is the product NDC for Levetiracetam, Levetiracetam 250 mg/1 tablet, film coated, listed with the FDA by Solco Healthcare US, LLC. It has 1 package NDC, 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 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 250 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-880 |
| 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 |