Prescription drug · ANDA
Levetiracetam (levetiracetam injection) NDC 43598-635
Levetiracetam 5 mg/mL · Injection · Intravenous · Dr.Reddy's Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-635-10 | 43598063510 | 10 BAG in 1 CARTON (43598-635-10) / 100 mL in 1 BAG (43598-635-52)Marketed from Jun 8, 2018 |
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 injection
- Active ingredients
- Levetiracetam — 5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Dr.Reddy's Laboratories Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206880
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 43598-635_f5cfc6e1-79f3-bd25-5f66-9ea05bc47defSPL ID f5cfc6e1-79f3-bd25-5f66-9ea05bc47defSPL set ID 0a9234b7-46b1-8e6c-a992-90f86cfb6e00RxCUI 1193358, 1193360, 1193362UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N443598063510followed by a unit qualifier and the quantityPackage 43598-0635-10. 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 in Sodium Chloride Injection is an antiepileptic drug indicated for adult patients (16 years and older) when oral administration is temporarily not feasible. Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible: Partial onset seizures ( 1.1 ) Myoclonic seizures in patients with juvenile myoclonic epilepsy ( 1.2 ) Primary generalized tonic-clonic seizures ( 1.3 ) 1.1 Partial-Onset Seizures Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. 1.2 Myoclo…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206880
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 5 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-793 |
| levetiracetam | Levetiracetam 10 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-794 |
| levetiracetam | Levetiracetam 15 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-795 |
| Levetiracetamlevetiracetam injection | Levetiracetam 10 mg/mL | InjectionIntravenous | Dr.Reddy's Laboratories Inc | 43598-636 |
| Levetiracetamlevetiracetam injection | Levetiracetam 15 mg/mL | InjectionIntravenous | Dr.Reddy's Laboratories Inc | 43598-637 |
| Levetiracetamlevetiracetam injection | Levetiracetam 10 mg/mL | InjectionIntravenous | Dr.Reddy's Laboratories Inc | 43598-757 |
| Levetiracetamlevetiracetam injection | Levetiracetam 5 mg/mL | InjectionIntravenous | Dr.Reddy's Laboratories Inc | 43598-755 |
| Levetiracetamlevetiracetam injection | Levetiracetam 15 mg/mL | InjectionIntravenous | Dr.Reddy's Laboratories Inc | 43598-759 |
| Levetiracetam | Levetiracetam 15 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-154 |
| Levetiracetam | Levetiracetam 5 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-152 |
| Levetiracetam | Levetiracetam 10 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-153 |