Prescription drug · ANDA
Levetiracetam NDC 0143-9574
Levetiracetam 100 mg/mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9574-10 | 00143957410 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9574-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9574-01)Marketed from Jun 1, 2015 | |
| 0143-9574-25 | 00143957425 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9574-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9574-01)Marketed from Jun 1, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090981
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0143-9574_14e07144-d548-4e86-ab10-2e16ec58aab7SPL ID 14e07144-d548-4e86-ab10-2e16ec58aab7SPL set ID 097e5606-dd5e-4518-ab97-f71f68786444RxCUI 647121UNII 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
N400143957410followed by a unit qualifier and the quantityPackage 00143-9574-10. 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 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: 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 ) • 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 patients 1 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090981
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 100 mg/mL | InjectionIntravenous | Civica, Inc. | 72572-360 |
| Levetiracetam | Levetiracetam 100 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9673 |