Prescription drug · ANDA
Levetiracetam NDC 70518-3895
Levetiracetam 1000 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3895-0 | 70518389500 | 30 TABLET in 1 BLISTER PACK (70518-3895-0)Marketed from Oct 16, 2023 | |
| 70518-3895-1 | 70518389501 | 60 TABLET in 1 BOTTLE, PLASTIC (70518-3895-1)Marketed from Oct 2, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 1000 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091491
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 70518-3895_53e79433-7657-9388-e063-6394a90a960aSPL ID 53e79433-7657-9388-e063-6394a90a960aSPL set ID 23073db5-3fc4-4051-a22d-e49a63e42647RxCUI 387003UNII 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
N470518389500followed by a unit qualifier and the quantityPackage 70518-3895-00. 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 is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam 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) 1.1 Partial-Onset Seizures Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam is indicated as adjunctive therapy for the treatment of myoclonic seizures in …
Excerpt only. Read the full label for complete information.
About NDC 70518-3895
- What is NDC 70518-3895?
- 70518-3895 is the product NDC for Levetiracetam, Levetiracetam 1000 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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?
- 266 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 500 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-046 | 87441-0046-01 |
| Levetiracetam | Levetiracetam 1000 mg/1 | TabletOral | Direct_Rx | 72189-679 | 72189-0679-6072189-0679-82 |
| 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 091491
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 750 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-192 |
| Levetiracetam | Levetiracetam 250 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-190 |
| Levetiracetam | Levetiracetam 500 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-191 |
| Levetiracetam | Levetiracetam 1000 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-193 |
| Levetiracetam | Levetiracetam 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-7521 |
| Levetiracetam | Levetiracetam 250 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2275 |
| Levetiracetam | Levetiracetam 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-7820 |
| Levetiracetam | Levetiracetam 750 mg/1 | TabletOral | Cranbury Pharmaceuticals, LLC | 27808-265 |
| Levetiracetam | Levetiracetam 250 mg/1 | TabletOral | Cranbury Pharmaceuticals, LLC | 27808-263 |
| Levetiracetam | Levetiracetam 500 mg/1 | TabletOral | Cranbury Pharmaceuticals, LLC | 27808-264 |
| Levetiracetam | Levetiracetam 750 mg/1 | TabletOral | Coupler LLC | 67046-1207 |
| Levetiracetam | Levetiracetam 1000 mg/1 | TabletOral | Cranbury Pharmaceuticals, LLC | 27808-266 |
| Levetiracetam | Levetiracetam 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9757 |
| Levetiracetam | Levetiracetam 1000 mg/1 | TabletOral | Coupler LLC | 67046-1461 |
| Levetiracetam | Levetiracetam 500 mg/1 | TabletOral | Coupler LLC | 67046-2094 |
| Levetiracetam | Levetiracetam 1000 mg/1 | TabletOral | Direct_Rx | 72189-679 |
| Levetiracetam | Levetiracetam 500 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0566 |
| Levetiracetam | Levetiracetam 500 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0565 |
| Levetiracetam | Levetiracetam 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8843 |
| Levetiracetam | Levetiracetam 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4301 |
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