Prescription drug · NDA
Motpoly XR (Lacosamide) NDC 73289-0065
Lacosamide 200 mg/1 · Capsule, Extended release · Oral · Aucta Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73289-0065-2 | 73289006502 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (73289-0065-2)Marketed from May 5, 2023 |
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)
- Motpoly XR
- Generic name (nonproprietary)
- lacosamide
- Active ingredients
- Lacosamide — 200 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Aucta Pharmaceuticals, Inc.NDC labeler code 73289
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216185
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 73289-0065_3a10a8ff-87ff-a36b-e063-6394a90a473cSPL ID 3a10a8ff-87ff-a36b-e063-6394a90a473cSPL set ID fb8235b4-4cd3-6f22-e053-6294a90a545cRxCUI 2637018, 2637025, 2637027, 2637030, 2637032, 2637035UNII 563KS2PQY5
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
N473289006502followed by a unit qualifier and the quantityPackage 73289-0065-02. 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)
MOTPOLY XR is indicated for: Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg ( 1.1 ) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg (1.2) 1.1 Partial-Onset Seizures MOTPOLY XR is indicated for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg. 1.2 Primary Generalized Tonic-Clonic Seizures MOTPOLY XR is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg. Additional pediatric use information is approved …
Excerpt only. Read the full label for complete information.
About NDC 73289-0065
- What is NDC 73289-0065?
- 73289-0065 is the product NDC for Motpoly XR (lacosamide), Lacosamide 200 mg/1 capsule, extended release, listed with the FDA by Aucta Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Motpoly XR (Lacosamide).
- What is the active ingredient?
- Lacosamide.
- Who is the labeler?
- Aucta Pharmaceuticals, Inc., NDC labeler code 73289. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Motpoly XR?
- 2 other product NDCs are listed under this name. See all Motpoly XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Motpoly XR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Motpoly XRlacosamide | Lacosamide 100 mg/1 | Capsule, Extended releaseOral | Aucta Pharmaceuticals, Inc. | 73289-0063 | 73289-0063-0173289-0063-02 |
| Motpoly XRlacosamide | Lacosamide 150 mg/1 | Capsule, Extended releaseOral | Aucta Pharmaceuticals, Inc. | 73289-0064 | 73289-0064-02 |
Other NDCs under NDA 216185
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 |
|---|---|---|---|---|
| Motpoly XRlacosamide | Lacosamide 100 mg/1 | Capsule, Extended releaseOral | Aucta Pharmaceuticals, Inc. | 73289-0063 |
| Motpoly XRlacosamide | Lacosamide 150 mg/1 | Capsule, Extended releaseOral | Aucta Pharmaceuticals, Inc. | 73289-0064 |