Prescription drug · ANDA
Lamotrigine NDC 71335-2071
Lamotrigine 150 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2071-1 | 71335207101 | 60 TABLET in 1 BOTTLE (71335-2071-1)Marketed from Apr 3, 2024 | |
| 71335-2071-2 | 71335207102 | 30 TABLET in 1 BOTTLE (71335-2071-2)Marketed from Mar 25, 2022 | |
| 71335-2071-3 | 71335207103 | 90 TABLET in 1 BOTTLE (71335-2071-3)Marketed from Apr 3, 2024 | |
| 71335-2071-4 | 71335207104 | 120 TABLET in 1 BOTTLE (71335-2071-4)Marketed from Apr 3, 2024 | |
| 71335-2071-5 | 71335207105 | 180 TABLET in 1 BOTTLE (71335-2071-5)Marketed from Apr 3, 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 — 150 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 078525
- 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 71335-2071_8e3ac5b3-ad6e-4131-b523-8ed5cde59b00SPL ID 8e3ac5b3-ad6e-4131-b523-8ed5cde59b00SPL set ID 68a4dac2-5015-40c5-88ca-204098c3b288RxCUI 198428UNII 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
N471335207101followed by a unit qualifier and the quantityPackage 71335-2071-01. 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 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: Treatment of…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078525
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 100 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3944 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4132 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4130 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4131 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4133 |