Prescription drug · ANDA
Lamotrigine NDC 65841-686
Lamotrigine 200 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-686-05 | 65841068605 | 500 TABLET in 1 BOTTLE (65841-686-05)Marketed from Jan 27, 2009 | |
| 65841-686-14 | 65841068614 | 60 TABLET in 1 BOTTLE (65841-686-14)Marketed from Jan 27, 2009 | |
| 65841-686-16 | 65841068616 | 90 TABLET in 1 BOTTLE (65841-686-16)Marketed from Jan 27, 2009 |
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 — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- 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 65841-686_c4eb074b-9cd4-4bcd-868c-473d9364061cSPL ID c4eb074b-9cd4-4bcd-868c-473d9364061cSPL set ID 0f2f7421-56d4-45d0-9d2d-dc1edaede039RxCUI 198427, 198428, 198429, 199322, 249329, 282401, 311264, 311265UNII U3H27498KSUPC 0365841687057
- 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
N465841068605followed by a unit qualifier and the quantityPackage 65841-0686-05. 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 .
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 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 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2384 |
| 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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