Prescription drug · ANDA
Lacosamide Oral Solution (Lacosamide) NDC 62135-885
Lacosamide 10 mg/mL · Solution · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-885-22 | 62135088522 | 200 mL in 1 BOTTLE (62135-885-22)Marketed from Nov 27, 2024 | |
| 62135-885-23 | 62135088523 | 2 TRAY in 1 BOX (62135-885-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-885-10)Marketed from Feb 10, 2025 | |
| 62135-885-24 | 62135088524 | 2 TRAY in 1 BOX (62135-885-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-885-05)Marketed from Feb 10, 2025 |
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)
- Lacosamide Oral Solution
- Generic name (nonproprietary)
- lacosamide
- Active ingredients
- Lacosamide — 10 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215154
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 62135-885_2df7ee04-2970-8b37-e063-6294a90a29a4SPL ID 2df7ee04-2970-8b37-e063-6294a90a29a4SPL set ID 7197c0b6-5bb9-43b3-be1d-e7615629df9aRxCUI 993856UNII 563KS2PQY5UPC 0362135885229
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
N462135088522followed by a unit qualifier and the quantityPackage 62135-0885-22. 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)
Lacosamide Oral Solution is indicated for: Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2 ) 1.1 Partial-Onset Seizures Lacosamide oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide oral solution is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.
Excerpt only. Read the full label for complete information.
About NDC 62135-885
- What is NDC 62135-885?
- 62135-885 is the product NDC for Lacosamide Oral Solution (lacosamide), Lacosamide 10 mg/mL solution, listed with the FDA by Chartwell RX, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lacosamide Oral Solution (Lacosamide).
- What is the active ingredient?
- Lacosamide.
- Who is the labeler?
- Chartwell RX, LLC, NDC labeler code 62135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lacosamide Oral Solution?
- 7 other product NDCs are listed under this name. See all Lacosamide Oral Solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lacosamide Oral Solution products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lacosamide Oral Solutionlacosamide | Lacosamide 10 mg/mL | SolutionOral | AvKARE | 73190-103 | 73190-0103-20 |
| Lacosamide Oral Solutionlacosamide oral | Lacosamide 10 mg/mL | SolutionOral | Florida Pharmaceutical Products, LLC | 71921-411 | 71921-0411-71 |
| Lacosamide Oral Solutionlacosamide | Lacosamide 10 mg/mL | SolutionOral | Kesin Pharmaceutical Corporation | 81033-427 | 81033-0427-1481033-0427-1681033-0427-17+1 more |
| Lacosamide Oral Solutionlacosamide | Lacosamide 10 mg/mL | SolutionOral | Kesin Pharma Corporation | 81033-428 | 81033-0428-02 |
| Lacosamide Oral Solutionlacosamide | Lacosamide 10 mg/mL | SolutionOral | Ajenat Pharmaceuticals LLC | 82983-427 | 82983-0427-31 |
| Lacosamide Oral Solutionlacosamide | Lacosamide 10 mg/mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-885 | 68999-0885-2368999-0885-24 |
| Lacosamide Oral Solution | Lacosamide 10 mg/mL | SolutionOral | Ascend Laboratories, LLC | 67877-732 | 67877-0732-9567877-0732-97 |
Other NDCs under ANDA 215154
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 |
|---|---|---|---|---|
| Lacosamide Oral Solutionlacosamide | Lacosamide 10 mg/mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-885 |