Prescription drug · ANDA
Lamotrigine NDC 71335-2384
Lamotrigine 25 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2384-1 | 71335238401 | 30 TABLET in 1 BOTTLE (71335-2384-1)Marketed from Sep 6, 2024 | |
| 71335-2384-2 | 71335238402 | 60 TABLET in 1 BOTTLE (71335-2384-2)Marketed from Jun 16, 2025 | |
| 71335-2384-3 | 71335238403 | 90 TABLET in 1 BOTTLE (71335-2384-3)Marketed from Jun 16, 2025 | |
| 71335-2384-4 | 71335238404 | 100 TABLET in 1 BOTTLE (71335-2384-4)Marketed from Mar 28, 2024 | |
| 71335-2384-5 | 71335238405 | 120 TABLET in 1 BOTTLE (71335-2384-5)Marketed from Apr 15, 2024 | |
| 71335-2384-6 | 71335238406 | 14 TABLET in 1 BOTTLE (71335-2384-6)Marketed from Jun 16, 2025 |
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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077633
- 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 71335-2384_2cf33586-e48a-4b4e-b14b-33de2be63c1dSPL ID 2cf33586-e48a-4b4e-b14b-33de2be63c1dSPL set ID 2cf33586-e48a-4b4e-b14b-33de2be63c1dRxCUI 282401UNII 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
N471335238401followed by a unit qualifier and the quantityPackage 71335-2384-01. 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 is indicated for: Epilepsy — adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) 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 antiepileptic drug. ( 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 Treatm…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077633
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 | TabletOral | American Health Packaging | 68084-318 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | American Health Packaging | 68084-319 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-682 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7008 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-686 |
| Lamotrigine | Lamotrigine 50 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-683 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-684 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-685 |
| Lamotrigine | Lamotrigine 250 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-687 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-005 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8267 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7964 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-134 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-131 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-132 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-133 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Northstar Rx LLC. | 16714-196 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Northstar Rx LLC. | 16714-194 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Northstar Rx LLC. | 16714-195 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | Northstar Rx LLC. | 16714-197 |
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