Prescription drug · ANDA
Lamotrigine NDC 16714-627
Lamotrigine 300 mg/1 · Tablet, Extended release · Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-627-01 | 16714062701 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-627-01)Marketed from Jun 20, 2017 |
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)
- Lamotrigine
- Generic name (nonproprietary)
- lamotrigine
- Active ingredients
- Lamotrigine — 300 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- NorthStar Rx LLC
- 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 16714-627_77f5183c-b6b1-c8e4-2757-8d318ea6cf9dSPL ID 77f5183c-b6b1-c8e4-2757-8d318ea6cf9dSPL set ID 9ab07d6b-ae4a-a310-5572-b266676cd29eRxCUI 850087, 850091, 900156, 900164, 1098608, 1146690UNII 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
N416714062701followed by a unit qualifier and the quantityPackage 16714-0627-01. 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 (PGTC) and partial-onset 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 50 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4121 |
| 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 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 |