Prescription drug · ANDA
Lamotrigine Extended-Release (Lamotrigine) NDC 10370-256
Lamotrigine 300 mg/1 · Tablet, Film coated, Extended release · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10370-256-11 | 1037002561110370025611 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-256-11)Marketed from Jan 2, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 Extended-ReleaseSuffix: Extended-Release
- Generic name (nonproprietary)
- lamotrigine
- Active ingredients
- Lamotrigine — 300 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 10370
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201374
- 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 10370-256_4e8e57a4-ecd3-4fce-943c-1ad74ea1ecc6SPL ID 4e8e57a4-ecd3-4fce-943c-1ad74ea1ecc6SPL set ID d5ec4d58-c669-4ab4-ba62-b71007536854RxCUI 850087, 900156, 1098608, 1146690UNII U3H27498KSUPC 0310370334118, 0310370208112, 0310370256113, 0310370207115
- 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
N410370025611followed by a unit qualifier and the quantityPackage 10370-0256-11. 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 extended-release tablets are 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 Lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with…
Excerpt only. Read the full label for complete information.
About NDC 10370-256
- What is NDC 10370-256?
- 10370-256 is the product NDC for Lamotrigine Extended-Release (lamotrigine), Lamotrigine 300 mg/1 tablet, film coated, extended release, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lamotrigine Extended-Release (Lamotrigine).
- What is the active ingredient?
- Lamotrigine.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 10370. 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 Extended-Release?
- 3 other product NDCs are listed under this name. See all Lamotrigine Extended-Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lamotrigine Extended-Release 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 Extended-Releaselamotrigine | Lamotrigine 100 mg/1 | Tablet, Film coated, Extended releaseOral | Par Health USA, LLC | 10370-207 | 10370-0207-11 |
| Lamotrigine Extended-Releaselamotrigine | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | Par Health USA, LLC | 10370-208 | 10370-0208-11 |
| Lamotrigine Extended-Releaselamotrigine | Lamotrigine 250 mg/1 | Tablet, Film coated, Extended releaseOral | Par Health USA, LLC | 10370-334 | 10370-0334-11 |
Other NDCs under ANDA 201374
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 Extended-Releaselamotrigine | Lamotrigine 100 mg/1 | Tablet, Film coated, Extended releaseOral | Par Health USA, LLC | 10370-207 |
| Lamotrigine Extended-Releaselamotrigine | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | Par Health USA, LLC | 10370-208 |
| Lamotrigine Extended-Releaselamotrigine | Lamotrigine 250 mg/1 | Tablet, Film coated, Extended releaseOral | Par Health USA, LLC | 10370-334 |