Prescription drug · ANDA
Lamotrigine NDC 55154-2065
Lamotrigine 100 mg/1 · Tablet · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-2065-0 | 55154206500 | 10 BLISTER PACK in 1 BAG (55154-2065-0) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 22, 2009 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cardinal Health 107, LLCNDC labeler code 55154
- 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 55154-2065_cc4537ab-8839-4f4e-a232-0cf7a52d2f39SPL ID cc4537ab-8839-4f4e-a232-0cf7a52d2f39SPL set ID 20e156df-a2b6-4710-b526-0419cd17dd33RxCUI 198427UNII U3H27498KSUPC 0055154206501
- 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
N455154206500followed by a unit qualifier and the quantityPackage 55154-2065-00. 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: Tre…
Excerpt only. Read the full label for complete information.
About NDC 55154-2065
- What is NDC 55154-2065?
- 55154-2065 is the product NDC for Lamotrigine, Lamotrigine 100 mg/1 tablet, listed with the FDA by Cardinal Health 107, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lamotrigine.
- What is the active ingredient?
- Lamotrigine.
- Who is the labeler?
- Cardinal Health 107, LLC, NDC labeler code 55154. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lamotrigine?
- 259 other product NDCs are listed under this name. See all Lamotrigine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lamotrigine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lamotrigine | Lamotrigine 50 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4702 | 70518-4702-00 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Coupler LLC | 67046-0358 | 67046-0358-03 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Coupler LLC | 67046-0749 | 67046-0749-03 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Coupler LLC | 67046-0359 | 67046-0359-03 |
| lamotriginelamotrigine extended-release | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4638 | 70518-4638-00 |
| Lamotrigine | Lamotrigine 25 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-770 | 46708-0770-1546708-0770-30 |
| Lamotrigine | Lamotrigine 50 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-771 | 46708-0771-1546708-0771-30 |
| Lamotrigine | Lamotrigine 100 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-772 | 46708-0772-1046708-0772-30 |
| Lamotrigine | Lamotrigine 200 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-773 | 46708-0773-1046708-0773-30 |
| Lamotrigine | Lamotrigine 25 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Inc. | 62332-770 | 62332-0770-1562332-0770-30 |
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7964 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7975 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8150 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8267 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7007 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7008 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Northstar Rx LLC. | 16714-194 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Northstar Rx LLC. | 16714-195 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Northstar Rx LLC. | 16714-196 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | Northstar Rx LLC. | 16714-197 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | A-S Medication Solutions | 50090-5850 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2330 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2331 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | American Health Packaging | 60687-693 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | American Health Packaging | 60687-704 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-682 |
| 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 200 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-686 |
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