Prescription drug · ANDA
Levetiracetam NDC 67877-770
Levetiracetam 750 mg/1 · Tablet, Film coated · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-770-05 | 67877077005 | 500 TABLET, FILM COATED in 1 BOTTLE (67877-770-05)Marketed from May 28, 2022 | |
| 67877-770-12 | 67877077012 | 120 TABLET, FILM COATED in 1 BOTTLE (67877-770-12)Marketed from May 28, 2022 | |
| 67877-770-30 | 67877077030 | 30 TABLET, FILM COATED in 1 BOTTLE (67877-770-30)Marketed from May 28, 2022 | |
| 67877-770-33 | 67877077033 | 1 BLISTER PACK in 1 CARTON (67877-770-33) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 28, 2022 |
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 — 750 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216375
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 67877-770_a5806e80-3237-4959-8a78-2e1d0905c137SPL ID a5806e80-3237-4959-8a78-2e1d0905c137SPL set ID 591dd9f1-3681-4b2f-b096-7536826e3648RxCUI 311288, 311289, 311290, 387003UNII 44YRR34555UPC 0367877770055, 0367877771601
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
N467877077005followed by a unit qualifier and the quantityPackage 67877-0770-05. 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 tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Levetiracetam tablets are 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 tablets are 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 tablets are indicated as adjunctive thera…
Excerpt only. Read the full label for complete information.
About NDC 67877-770
- What is NDC 67877-770?
- 67877-770 is the product NDC for Levetiracetam, Levetiracetam 750 mg/1 tablet, film coated, listed with the FDA by Ascend Laboratories, LLC. 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?
- Ascend Laboratories, LLC, NDC labeler code 67877. 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 216375
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 | Ascend Laboratories, LLC | 67877-771 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-768 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-769 |