Prescription drug · NDA
Lamictal (Lamotrigine) NDC 0173-0633
Lamotrigine 25 mg/1 · Tablet · Oral · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0633-02 | 00173063302 | 100 TABLET in 1 BOTTLE (0173-0633-02)Marketed from Aug 15, 1996 | |
| 0173-0633-10 | 00173063310 | 35 TABLET in 1 DOSE PACK (0173-0633-10)Marketed from Aug 15, 1996 |
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
- Generic name (nonproprietary)
- lamotrigine
- Active ingredients
- Lamotrigine — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- GlaxoSmithKline LLCNDC labeler code 0173
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020241
- 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 0173-0633_076c76e0-4a5e-491b-ba85-de2dd757b436SPL ID 076c76e0-4a5e-491b-ba85-de2dd757b436SPL set ID d7e3572d-56fe-4727-2bb4-013ccca22678RxCUI 103968, 105018, 105019, 108782, 198427, 198428, 198429, 198430, 201239, 201240, 206201, 252478, 252479, 282401, 311264, 311265, 349010, 542426, 751139, 751563, 753451, 795772, 795774, 795778, 849049, 849050, 849051, 849052, 851748, 851749, 851750, 851751, 851752, 851753UNII U3H27498KSUPC 0301730526007, 0301730644602, 0301730699008, 0301730642554, 0301730643605, 0301730527004
- 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
N400173063302followed by a unit qualifier and the quantityPackage 00173-0633-02. 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 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: Tr…
Excerpt only. Read the full label for complete information.
About NDC 0173-0633
- What is NDC 0173-0633?
- 0173-0633 is the product NDC for Lamictal (lamotrigine), Lamotrigine 25 mg/1 tablet, listed with the FDA by GlaxoSmithKline LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lamictal (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?
- 8 other product NDCs are listed under this name. See all Lamictal NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lamictal products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lamictallamotrigine | — | Kit | GlaxoSmithKline LLC | 0173-0594 | 00173-0594-02 |
| Lamictallamotrigine | — | Kit | GlaxoSmithKline LLC | 0173-0817 | 00173-0817-28 |
| Lamictallamotrigine | Lamotrigine 2 mg/1 | Tablet, For suspensionOral | GlaxoSmithKline LLC | 0173-0699 | 00173-0699-0000173-0699-02 |
| Lamictallamotrigine | Lamotrigine 5 mg/1 | Tablet, For suspensionOral | GlaxoSmithKline LLC | 0173-0526 | 00173-0526-00 |
| Lamictallamotrigine | Lamotrigine 25 mg/1 | Tablet, For suspensionOral | GlaxoSmithKline LLC | 0173-0527 | 00173-0527-00 |
| Lamictallamotrigine | Lamotrigine 200 mg/1 | TabletOral | GlaxoSmithKline LLC | 0173-0644 | 00173-0644-60 |
| Lamictallamotrigine | Lamotrigine 100 mg/1 | TabletOral | GlaxoSmithKline LLC | 0173-0642 | 00173-0642-55 |
| Lamictallamotrigine | Lamotrigine 150 mg/1 | TabletOral | GlaxoSmithKline LLC | 0173-0643 | 00173-0643-60 |
Other NDCs under NDA 020241
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 |
|---|---|---|---|---|
| Lamictallamotrigine | — | Kit | GlaxoSmithKline LLC | 0173-0594 |
| Lamictallamotrigine | — | Kit | GlaxoSmithKline LLC | 0173-0817 |
| Lamictallamotrigine | Lamotrigine 100 mg/1 | TabletOral | GlaxoSmithKline LLC | 0173-0642 |
| Lamictallamotrigine | Lamotrigine 150 mg/1 | TabletOral | GlaxoSmithKline LLC | 0173-0643 |
| Lamictallamotrigine | Lamotrigine 200 mg/1 | TabletOral | GlaxoSmithKline LLC | 0173-0644 |