Prescription drug · ANDA
Lamotrigine NDC 0115-1527
Lamotrigine 50 mg/1 · Tablet, Orally disintegrating · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0115-1527-08 | 00115152708 | 2 BLISTER PACK in 1 CARTON (0115-1527-08) / 15 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-1527-68)Marketed from Jan 9, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 50 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200828
- 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 0115-1527_9611e358-6fe1-4f8d-99a2-250a7862a896SPL ID 9611e358-6fe1-4f8d-99a2-250a7862a896SPL set ID 380bddae-5b31-4965-96de-97711d859d11RxCUI 103968, 198430, 252478, 252479UNII 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
N400115152708followed by a unit qualifier and the quantityPackage 00115-1527-08. 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 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: Treatment of acute manic o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200828
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 25 mg/1 | Tablet, Orally disintegratingOral | Amneal Pharmaceuticals of New York LLC | 0115-1526 |
| Lamotrigine | Lamotrigine 200 mg/1 | Tablet, Orally disintegratingOral | Amneal Pharmaceuticals of New York LLC | 0115-1529 |
| Lamotrigine | Lamotrigine 25 mg/1 | Tablet, Orally disintegratingOral | Amneal Pharmaceuticals of New York LLC | 0115-9939 |
| Lamotrigine | Lamotrigine 50 mg/1 | Tablet, Orally disintegratingOral | Amneal Pharmaceuticals of New York LLC | 0115-9940 |
| Lamotrigine | Lamotrigine 100 mg/1 | Tablet, Orally disintegratingOral | Amneal Pharmaceuticals of New York LLC | 0115-9941 |
| Lamotrigine | Lamotrigine 200 mg/1 | Tablet, Orally disintegratingOral | Amneal Pharmaceuticals of New York LLC | 0115-9942 |
| Lamotrigine | Lamotrigine 100 mg/1 | Tablet, Orally disintegratingOral | Amneal Pharmaceuticals of New York LLC | 0115-1528 |