Prescription drug · ANDA
Levetiracetam ER (Levetiracetam) NDC 69367-333
Levetiracetam 750 mg/1 · Tablet, Film coated, Extended release · Oral · Westminster Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69367-333-60 | 69367033360 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69367-333-60)Marketed from Sep 30, 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 ERSuffix: ER
- Generic name (nonproprietary)
- levetiracetam
- Active ingredients
- Levetiracetam — 750 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Westminster Pharmaceuticals, LLCNDC labeler code 69367
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205130
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 69367-333_18d684d2-22a4-497a-ab10-f35ef53408ceSPL ID 18d684d2-22a4-497a-ab10-f35ef53408ceSPL set ID c508a392-0603-477d-8a45-3ec550371111RxCUI 807832, 846378UNII 44YRR34555UPC 0369367332606, 0369367333603
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
N469367033360followed by a unit qualifier and the quantityPackage 69367-0333-60. 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 extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older. Levetiracetam is indicated for the treatment of partial-onset seizures in patients 12 years of age and older ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 69367-333
- What is NDC 69367-333?
- 69367-333 is the product NDC for Levetiracetam ER (levetiracetam), Levetiracetam 750 mg/1 tablet, film coated, extended release, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levetiracetam ER (Levetiracetam).
- What is the active ingredient?
- Levetiracetam.
- Who is the labeler?
- Westminster Pharmaceuticals, LLC, NDC labeler code 69367. 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 ER?
- 6 other product NDCs are listed under this name. See all Levetiracetam ER NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Levetiracetam ER 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 ERlevetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4125 | 70518-4125-00 |
| Levetiracetam ER | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | Direct_Rx | 72189-510 | 72189-0510-60 |
| Levetiracetam ERlevetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-332 | 69367-0332-60 |
| Levetiracetam ERlevetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 71205-728 | 71205-0728-3071205-0728-6071205-0728-90 |
| Levetiracetam ERlevetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 71205-880 | 71205-0880-0071205-0880-1171205-0880-30+6 more |
| Levetiracetam ERlevetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 71205-881 | 71205-0881-0071205-0881-1171205-0881-30+6 more |
Other NDCs under ANDA 205130
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 ERlevetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-332 |
| Levetiracetam ERlevetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4125 |
| Levetiracetam ERlevetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 71205-728 |
| Levetiracetam ERlevetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 71205-880 |
| Levetiracetam ERlevetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 71205-881 |
| Levetiracetam Extended-Releaselevetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-189 |
| Levetiracetam Extended-Releaselevetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-190 |