Prescription drug · ANDA
LEVETIRACETAM solution (Levetiracetam) NDC 62135-548
Levetiracetam 100 mg/mL · Solution · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-548-47 | 62135054847 | 473 mL in 1 BOTTLE (62135-548-47)Marketed from Jun 8, 2022 |
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 solution
- Generic name (nonproprietary)
- levetiracetam
- Active ingredients
- Levetiracetam — 100 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090263
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 62135-548_4ce97296-8459-d216-e063-6394a90a1f42SPL ID 4ce97296-8459-d216-e063-6394a90a1f42SPL set ID 61eb57a9-5df2-4426-9f0c-a75e2f356b11RxCUI 403884UNII 44YRR34555UPC 0362135548476
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
N462135054847followed by a unit qualifier and the quantityPackage 62135-0548-47. 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 seizur…
Excerpt only. Read the full label for complete information.
About NDC 62135-548
- What is NDC 62135-548?
- 62135-548 is the product NDC for LEVETIRACETAM solution (levetiracetam), Levetiracetam 100 mg/mL solution, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- LEVETIRACETAM solution (Levetiracetam).
- What is the active ingredient?
- Levetiracetam.
- Who is the labeler?
- Chartwell RX, LLC, NDC labeler code 62135. 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 solution?
- 1 other product NDC are listed under this name. See all LEVETIRACETAM solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other LEVETIRACETAM solution 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 solutionlevetiracetam | Levetiracetam 100 mg/mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-548 | 68999-0548-24 |
Other NDCs under ANDA 090263
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 solutionlevetiracetam | Levetiracetam 100 mg/mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-548 |