Prescription drug · NDA
Lamictal ODT (Lamotrigine) NDC 0173-0777
Lamotrigine 200 mg/1 · Tablet, Orally disintegrating · Oral · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0777-02 | 0017307770200173077702 | 1 DOSE PACK in 1 CARTON (0173-0777-02) / 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACKMarketed from Jun 5, 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)
- Lamictal ODTSuffix: ODT
- Generic name (nonproprietary)
- lamotrigine
- Active ingredients
- Lamotrigine — 200 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- GlaxoSmithKline LLCNDC labeler code 0173
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022251
- 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 0173-0777_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
N400173077702followed by a unit qualifier and the quantityPackage 00173-0777-02. 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 0173-0777
- What is NDC 0173-0777?
- 0173-0777 is the product NDC for Lamictal ODT (lamotrigine), Lamotrigine 200 mg/1 tablet, orally disintegrating, 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 ODT (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 ODT?
- 6 other product NDCs are listed under this name. See all Lamictal ODT NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lamictal ODT 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 ODTlamotrigine | Lamotrigine 25 mg/1 | Tablet, Orally disintegratingOral | GlaxoSmithKline LLC | 0173-0772 | 00173-0772-02 |
| Lamictal ODTlamotrigine | Lamotrigine 50 mg/1 | Tablet, Orally disintegratingOral | GlaxoSmithKline LLC | 0173-0774 | 00173-0774-02 |
| Lamictal ODTlamotrigine | Lamotrigine 100 mg/1 | Tablet, Orally disintegratingOral | GlaxoSmithKline LLC | 0173-0776 | 00173-0776-02 |
| Lamictal ODTlamotrigine | — | Kit | GlaxoSmithKline LLC | 0173-0778 | 00173-0778-00 |
| Lamictal ODTlamotrigine | — | Kit | GlaxoSmithKline LLC | 0173-0779 | 00173-0779-00 |
| Lamictal ODTlamotrigine | — | Kit | GlaxoSmithKline LLC | 0173-0780 | 00173-0780-00 |
Other NDCs under NDA 022251
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 ODTlamotrigine | Lamotrigine 25 mg/1 | Tablet, Orally disintegratingOral | GlaxoSmithKline LLC | 0173-0772 |
| Lamictal ODTlamotrigine | Lamotrigine 50 mg/1 | Tablet, Orally disintegratingOral | GlaxoSmithKline LLC | 0173-0774 |
| Lamictal ODTlamotrigine | Lamotrigine 100 mg/1 | Tablet, Orally disintegratingOral | GlaxoSmithKline LLC | 0173-0776 |
| Lamictal ODTlamotrigine | — | Kit | GlaxoSmithKline LLC | 0173-0778 |
| Lamictal ODTlamotrigine | — | Kit | GlaxoSmithKline LLC | 0173-0779 |
| Lamictal ODTlamotrigine | — | Kit | GlaxoSmithKline LLC | 0173-0780 |