Prescription drug · ANDA
Levetiracetam (Levetiracetam in sodium chloride) NDC 65145-173
Levetiracetam 500 mg/100mL · Injection · Intravenous · Caplin Steriles Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65145-173-10 | 6514501731065145017310 | 10 POUCH in 1 CASE (65145-173-10) / 1 BAG in 1 POUCH (65145-173-01) / 100 mL in 1 BAGMarketed from Jun 24, 2025 |
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 in sodium chloride
- Active ingredients
- Levetiracetam — 500 mg/100mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Caplin Steriles LimitedNDC labeler code 65145
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219562
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 65145-173_b14657e5-789e-4933-aeb9-78509d79b792SPL ID b14657e5-789e-4933-aeb9-78509d79b792SPL set ID 563171fb-df26-4f95-853a-fd7707da291cRxCUI 1193358, 1193360, 1193362UNII 44YRR34555UPC 0365145175014, 0365145174017, 0365145173010
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
N465145017310followed by a unit qualifier and the quantityPackage 65145-0173-10. 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 the treatment 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 seizur…
Excerpt only. Read the full label for complete information.
About NDC 65145-173
- What is NDC 65145-173?
- 65145-173 is the product NDC for Levetiracetam (levetiracetam in sodium chloride), Levetiracetam 500 mg/100mL injection, listed with the FDA by Caplin Steriles Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levetiracetam (Levetiracetam in Sodium Chloride).
- What is the active ingredient?
- Levetiracetam.
- Who is the labeler?
- Caplin Steriles Limited, NDC labeler code 65145. 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 219562
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 |
|---|---|---|---|---|
| Levetiracetamlevetiracetam in sodium chloride | Levetiracetam 1000 mg/100mL | InjectionIntravenous | Caplin Steriles Limited | 65145-174 |
| Levetiracetamlevetiracetam in sodium chloride | Levetiracetam 1500 mg/100mL | InjectionIntravenous | Caplin Steriles Limited | 65145-175 |
| Levetiracetamlevetiracetam in sodium chloride | Levetiracetam 500 mg/100mL | InjectionIntravenous | Somerset Therapeutics, LLC | 70069-845 |
| Levetiracetamlevetiracetam in sodium chloride | Levetiracetam 1000 mg/100mL | InjectionIntravenous | Somerset Therapeutics, LLC | 70069-846 |
| Levetiracetamlevetiracetam in sodium chloride | Levetiracetam 1500 mg/100mL | InjectionIntravenous | Somerset Therapeutics, LLC | 70069-847 |