Prescription drug · ANDA
Lamotrigine NDC 70518-4121
Lamotrigine 50 mg/1 · Tablet, Extended release · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4121-0 | 70518412100 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4121-0)Marketed from Jul 10, 2024 |
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)
- Lamotrigine
- Generic name (nonproprietary)
- lamotrigine
- Active ingredients
- Lamotrigine — 50 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202383
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)Dihydrofolate Reductase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-4121_4d65e768-faa2-1d32-e063-6394a90a93ddSPL ID 4d65e768-faa2-1d32-e063-6394a90a93ddSPL set ID 260dc37d-6e64-4688-82dc-10a1a428af17RxCUI 850091UNII U3H27498KS
- Pharmacologic class
- Anti-epileptic Agent; Mood Stabilizer
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
N470518412100followed by a unit qualifier and the quantityPackage 70518-4121-00. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Lamotrigine extended-release tablets are indicated for: adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset (PGTC) seizures with or without secondary generalization in patients aged 13 years and older. (1.1) conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). (1.2) Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. (1.3) 1.1 Adjunctive Therapy Lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or wi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202383
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 |
|---|---|---|---|---|
| Lamotrigine | Lamotrigine 250 mg/1 | Tablet, Extended releaseOral | NorthStar Rx LLC | 16714-893 |
| Lamotrigine | Lamotrigine 250 mg/1 | Tablet, Extended releaseOral | Dr.Reddy's Laboratories Limited | 55111-419 |
| Lamotrigine | Lamotrigine 300 mg/1 | Tablet, Extended releaseOral | Dr.Reddy's Laboratories Limited | 55111-428 |
| Lamotrigine | Lamotrigine 100 mg/1 | Tablet, Extended releaseOral | NorthStar Rx LLC | 16714-625 |
| Lamotrigine | Lamotrigine 25 mg/1 | Tablet, Extended releaseOral | NorthStar Rx LLC | 16714-623 |
| Lamotrigine | Lamotrigine 50 mg/1 | Tablet, Extended releaseOral | NorthStar Rx LLC | 16714-624 |
| Lamotrigine | Lamotrigine 200 mg/1 | Tablet, Extended releaseOral | NorthStar Rx LLC | 16714-626 |
| Lamotrigine | Lamotrigine 300 mg/1 | Tablet, Extended releaseOral | NorthStar Rx LLC | 16714-627 |
| Lamotrigine | Lamotrigine 50 mg/1 | Tablet, Extended releaseOral | Dr.Reddy's Laboratories Limited | 55111-718 |
| Lamotrigine | Lamotrigine 25 mg/1 | Tablet, Extended releaseOral | Dr.Reddy's Laboratories Limited | 55111-717 |
| Lamotrigine | Lamotrigine 100 mg/1 | Tablet, Extended releaseOral | Dr.Reddy's Laboratories Limited | 55111-719 |
| Lamotrigine | Lamotrigine 200 mg/1 | Tablet, Extended releaseOral | Dr.Reddy's Laboratories Limited | 55111-720 |