Prescription drug · ANDA
Levetiracetam NDC 36000-265
Levetiracetam 100 mg/mL · Injection, Solution, Concentrate · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36000-265-05 | 3600002650536000026505 | 5 VIAL, SINGLE-DOSE in 1 CARTON (36000-265-05) / 5 mL in 1 VIAL, SINGLE-DOSE (36000-265-01)Marketed from Aug 6, 2026 | |
| 36000-265-10 | 3600002651036000026510 | 10 VIAL, SINGLE-DOSE in 1 CARTON (36000-265-10) / 5 mL in 1 VIAL, SINGLE-DOSE (36000-265-01)Marketed from Aug 6, 2026 |
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 — 100 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 36000
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208458
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 36000-265_3312be87-d596-4fbe-91f6-9bacf7ac8869SPL ID 3312be87-d596-4fbe-91f6-9bacf7ac8869SPL set ID 8e381590-1147-46f3-9cbd-dc9716013444RxCUI 647121UNII 44YRR34555UPC 0336000265102, 0336000265010
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
N436000026505followed by a unit qualifier and the quantityPackage 36000-0265-05. 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 injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) • Levetiracetam injection is indicated for adjunctive therapy for the treatment of: o Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2 ) o Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3 ) • Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible ( 1.4 ) 1.1 Partial-Onset Seizures Levetiracetam injection is indicated for the treatment of partial-onset seizures in patie…
Excerpt only. Read the full label for complete information.
About NDC 36000-265
- What is NDC 36000-265?
- 36000-265 is the product NDC for Levetiracetam, Levetiracetam 100 mg/mL injection, solution, concentrate, listed with the FDA by Baxter Healthcare Corporation. It has 2 package NDCs, 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?
- Baxter Healthcare Corporation, NDC labeler code 36000. 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 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 |
| Levetiracetamlevetiracetam in sodium chloride | Levetiracetam 500 mg/100mL | InjectionIntravenous | Somerset Therapeutics, LLC | 70069-845 | 70069-0845-10 |