Prescription drug · ANDA
Levetiracetam (Levetiracetam injection) NDC 43598-759
Levetiracetam 15 mg/mL · Injection · Intravenous · Dr.Reddy's Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-759-10 | 4359807591043598075910 | 10 BAG in 1 CARTON (43598-759-10) / 100 mL in 1 BAG (43598-759-52)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 — 15 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Dr.Reddy's Laboratories IncNDC labeler code 43598
- 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 43598-759_b6d4150a-3849-e804-02cb-468a6593dd71SPL ID b6d4150a-3849-e804-02cb-468a6593dd71SPL set ID be8ec971-c4f1-3e53-77e1-8337d9d506ebRxCUI 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
N443598075910followed by a unit qualifier and the quantityPackage 43598-0759-10. 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 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 thetreatment of partial-onset seizures in adults with epilepsy. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of myoclonic seizure…
Excerpt only. Read the full label for complete information.
About NDC 43598-759
- What is NDC 43598-759?
- 43598-759 is the product NDC for Levetiracetam (levetiracetam injection), Levetiracetam 15 mg/mL injection, listed with the FDA by Dr.Reddy's Laboratories Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levetiracetam (Levetiracetam Injection).
- What is the active ingredient?
- Levetiracetam.
- Who is the labeler?
- Dr.Reddy's Laboratories Inc, NDC labeler code 43598. 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?
- 260 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 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 |
| 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 |
| Levetiracetamlevetiracetam injection | Levetiracetam 5 mg/mL | InjectionIntravenous | Dr.Reddy's Laboratories Inc | 43598-635 |
| 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 5 mg/mL | InjectionIntravenous | Dr.Reddy's Laboratories Inc | 43598-755 |
| Levetiracetamlevetiracetam injection | Levetiracetam 10 mg/mL | InjectionIntravenous | Dr.Reddy's Laboratories Inc | 43598-757 |