Prescription drug · ANDA
Lamotrigine NDC 42291-366
Lamotrigine 25 mg/1 · Tablet · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-366-01 | 42291036601 | 100 TABLET in 1 BOTTLE (42291-366-01)Marketed from Apr 10, 2013 | |
| 42291-366-10 | 42291036610 | 1000 TABLET in 1 BOTTLE (42291-366-10)Marketed from Jan 28, 2015 |
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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079132
- 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 42291-366_51b57ded-2d7d-d540-e063-6394a90a4744SPL ID 51b57ded-2d7d-d540-e063-6394a90a4744SPL set ID fcdb94a8-33be-6375-98ef-6933999d157fRxCUI 198427, 198428, 198429, 282401UNII U3H27498KSUPC 0342291368606
- 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
N442291036601followed by a unit qualifier and the quantityPackage 42291-0366-01. 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)
1. INDICATIONS AND USAGE Lamotrigine is indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic seizures. generalized seizures of Lennox-Gastaut syndrome. (1.1) Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED. (1.1) Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatmen…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079132
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 150 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-4697 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | AvKARE | 42291-367 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | AvKARE | 42291-368 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | AvKARE | 42291-369 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Jubilant Cadista Pharmacuticals Inc. | 59746-247 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Jubilant Cadista Pharmacuticals Inc. | 59746-245 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Jubilant Cadista Pharmacuticals Inc. | 59746-246 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | Jubilant Cadista Pharmacuticals Inc. | 59746-248 |