Prescription drug · ANDA
Levetiracetam NDC 72189-190
Levetiracetam 250 mg/1 · Tablet, Film coated · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-190-30 | 7218901903072189019030 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-190-30)Marketed from Jun 7, 2021 | |
| 72189-190-60 | 7218901906072189019060 | 60 TABLET, FILM COATED in 1 BOTTLE (72189-190-60)Marketed from Jun 7, 2021 | |
| 72189-190-72 | 7218901907272189019072 | 120 TABLET, FILM COATED in 1 BOTTLE (72189-190-72)Marketed from Jun 7, 2021 | |
| 72189-190-90 | 7218901909072189019090 | 90 TABLET, FILM COATED in 1 BOTTLE (72189-190-90)Marketed from Jun 7, 2021 |
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 — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- DIRECT RXNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090515
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 72189-190_4c4bd407-ac66-f594-e063-6294a90a31feSPL ID 4c4bd407-ac66-f594-e063-6294a90a31feSPL set ID c3b62114-a590-f4db-e053-2995a90a9d30RxCUI 311288, 311289UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472189019030followed by a unit qualifier and the quantityPackage 72189-0190-30. 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)
1.1 Partial Onset Seizures Levetiracetam tablet is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam tablet is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures Levetiracetam tablet is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
Excerpt only. Read the full label for complete information.
About NDC 72189-190
- What is NDC 72189-190?
- 72189-190 is the product NDC for Levetiracetam, Levetiracetam 250 mg/1 tablet, film coated, listed with the FDA by DIRECT RX. It has 4 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?
- DIRECT RX, NDC labeler code 72189. 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 090515
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 1000 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-539 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1901 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-152 |
| Levetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-189 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-187 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-188 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-190 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-310 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6086 |
| Levetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-537 |
| Levetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-123 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-121 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1333 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-122 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-124 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Injecta Medcial LLC | 87234-0035 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-034 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-035 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-325 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2875 |
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