Prescription drug · ANDA
Lamotrigine NDC 0615-7975
Lamotrigine 100 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0615-7975Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00615-7975Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-7975-39 | 0061579753900615797539 | 30 TABLET in 1 BLISTER PACK (0615-7975-39)Marketed from Jan 27, 2009 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- 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 0615-7975_791b0966-9fe1-471d-9800-0c82e5751296SPL ID 791b0966-9fe1-471d-9800-0c82e5751296SPL set ID e243e803-e95f-47a6-a6da-5fed657f4462RxCUI 198427, 198428, 198429, 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
N400615797539followed by a unit qualifier and the quantityPackage 00615-7975-39. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 0615-7975
- What is NDC 0615-7975?
- 0615-7975 is the product NDC for Lamotrigine, Lamotrigine 100 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. 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?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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?
- 262 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 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 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-5827 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | A-S Medication Solutions | 50090-5850 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2065 |
| 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 |
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