Prescription drug · NDA
Lamictal XR (Lamotrigine) NDC 0173-0781
Lamotrigine 250 mg/1 · Tablet, Film coated, Extended release · Oral · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0781-00 | 0017307810000173078100 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0781-00)Marketed from Aug 15, 2011 |
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)
- Lamictal XRSuffix: XR
- Generic name (nonproprietary)
- lamotrigine
- Active ingredients
- Lamotrigine — 250 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- GlaxoSmithKline LLCNDC labeler code 0173
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022115
- 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 0173-0781_d0cca76f-809f-4db8-a468-619a217debc1SPL ID d0cca76f-809f-4db8-a468-619a217debc1SPL set ID 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09RxCUI 850087, 850091, 900145, 900156, 900157, 900164, 900165, 900169, 900865, 900866, 900890, 900891, 900983, 900984, 1098608, 1098610, 1146690, 1146692UNII U3H27498KSUPC 0301730756008, 0301730757005, 0301730761002, 0301730754004, 0301730781000
- 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
N400173078100followed by a unit qualifier and the quantityPackage 00173-0781-00. 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)
LAMICTAL XR is indicated for: • adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1 ) • conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). ( 1.2 ) Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. ( 1.3 ) 1.1 Adjunctive Therapy LAMICTAL XR is indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients…
Excerpt only. Read the full label for complete information.
About NDC 0173-0781
- What is NDC 0173-0781?
- 0173-0781 is the product NDC for Lamictal XR (lamotrigine), Lamotrigine 250 mg/1 tablet, film coated, extended release, listed with the FDA by GlaxoSmithKline LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lamictal XR (Lamotrigine).
- What is the active ingredient?
- Lamotrigine.
- Who is the labeler?
- GlaxoSmithKline LLC, NDC labeler code 0173. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lamictal XR?
- 8 other product NDCs are listed under this name. See all Lamictal XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lamictal XR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lamictal XRlamotrigine | Lamotrigine 300 mg/1 | Tablet, Film coated, Extended releaseOral | GlaxoSmithKline LLC | 0173-0761 | 00173-0761-00 |
| Lamictal XRlamotrigine | Lamotrigine 25 mg/1 | Tablet, Film coated, Extended releaseOral | GlaxoSmithKline LLC | 0173-0754 | 00173-0754-00 |
| Lamictal XRlamotrigine | Lamotrigine 50 mg/1 | Tablet, Film coated, Extended releaseOral | GlaxoSmithKline LLC | 0173-0755 | 00173-0755-00 |
| Lamictal XRlamotrigine | Lamotrigine 100 mg/1 | Tablet, Film coated, Extended releaseOral | GlaxoSmithKline LLC | 0173-0756 | 00173-0756-00 |
| Lamictal XRlamotrigine | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | GlaxoSmithKline LLC | 0173-0757 | 00173-0757-00 |
| Lamictal XRlamotrigine | — | Kit | GlaxoSmithKline LLC | 0173-0758 | 00173-0758-00 |
| Lamictal XRlamotrigine | — | Kit | GlaxoSmithKline LLC | 0173-0759 | 00173-0759-00 |
| Lamictal XRlamotrigine | — | Kit | GlaxoSmithKline LLC | 0173-0760 | 00173-0760-00 |
Other NDCs under NDA 022115
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 |
|---|---|---|---|---|
| Lamictal XRlamotrigine | Lamotrigine 100 mg/1 | Tablet, Film coated, Extended releaseOral | GlaxoSmithKline LLC | 0173-0756 |
| Lamictal XRlamotrigine | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | GlaxoSmithKline LLC | 0173-0757 |
| Lamictal XRlamotrigine | — | Kit | GlaxoSmithKline LLC | 0173-0758 |
| Lamictal XRlamotrigine | — | Kit | GlaxoSmithKline LLC | 0173-0759 |
| Lamictal XRlamotrigine | Lamotrigine 300 mg/1 | Tablet, Film coated, Extended releaseOral | GlaxoSmithKline LLC | 0173-0761 |
| Lamictal XRlamotrigine | — | Kit | GlaxoSmithKline LLC | 0173-0760 |
| Lamictal XRlamotrigine | Lamotrigine 25 mg/1 | Tablet, Film coated, Extended releaseOral | GlaxoSmithKline LLC | 0173-0754 |
| Lamictal XRlamotrigine | Lamotrigine 50 mg/1 | Tablet, Film coated, Extended releaseOral | GlaxoSmithKline LLC | 0173-0755 |