Prescription drug · ANDA
Levetiracetam NDC 43063-617
Levetiracetam 500 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-617-60 | 43063061760 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-617-60)Marketed from Aug 1, 2015 |
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 — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078154
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 43063-617_53c43c71-6030-5313-e063-6294a90a3108SPL ID 53c43c71-6030-5313-e063-6294a90a3108SPL set ID c4b2da6a-ed50-4a54-90bd-32f76b178736RxCUI 311289UNII 44YRR34555UPC 0343063617601
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
N443063061760followed by a unit qualifier and the quantityPackage 43063-0617-60. 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 tablets USP are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam tablets USP are indicated for adjunctive therapy for treatment of: Partial onset seizures in patients one month of age and older with epilepsy ( 1.1 ) 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 tablets USP are indicated for treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with J…
Excerpt only. Read the full label for complete information.
About NDC 43063-617
- What is NDC 43063-617?
- 43063-617 is the product NDC for Levetiracetam, Levetiracetam 500 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 1 package NDC, 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?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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?
- 261 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 078154
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 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-360 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4137 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4675 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-112 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-113 |
| Levetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-114 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-8254 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1108 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1772 |
| Levetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2098 |