Prescription drug · ANDA
lamotrigine (lamotrigine extended-release) NDC 31722-244
Lamotrigine 250 mg/1 · Tablet, Film coated, Extended release · Oral · Camber Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-244-30 | 31722024430 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-244-30)Marketed from Dec 9, 2021 |
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
- Generic name (nonproprietary)
- lamotrigine extended-release
- Active ingredients
- Lamotrigine — 250 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Camber Pharmaceuticals Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213949
- 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 31722-244_49d44873-5b65-b8c2-e063-6294a90aa196SPL ID 49d44873-5b65-b8c2-e063-6294a90aa196SPL set ID e45bd69f-3580-ff15-e053-2a95a90a4615RxCUI 850087, 850091, 900156, 900164, 1098608, 1146690UNII U3H27498KSUPC 0331722243308, 0331722242301, 0331722241304, 0331722240307, 0331722245302, 0331722244305
- 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
N431722024430followed by a unit qualifier and the quantityPackage 31722-0244-30. 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 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 or with…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213949
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 |
|---|---|---|---|---|
| lamotriginelamotrigine extended-release | Lamotrigine 50 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0045 |
| lamotriginelamotrigine extended-release | Lamotrigine 25 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0044 |
| lamotriginelamotrigine extended-release | Lamotrigine 250 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0048 |
| lamotriginelamotrigine extended-release | Lamotrigine 100 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0046 |
| lamotriginelamotrigine extended-release | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0047 |
| lamotriginelamotrigine extended-release | Lamotrigine 300 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0049 |
| lamotriginelamotrigine extended-release | Lamotrigine 100 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-242 |
| lamotriginelamotrigine extended-release | Lamotrigine 25 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-240 |
| lamotriginelamotrigine extended-release | Lamotrigine 50 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-241 |
| lamotriginelamotrigine extended-release | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-243 |
| lamotriginelamotrigine extended-release | Lamotrigine 300 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-245 |
| lamotriginelamotrigine extended-release | Lamotrigine 50 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 82804-022 |
| Lamotrigine ER | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | Direct_rx | 72189-560 |
| lamotriginelamotrigine extended-release | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4638 |
| lamotriginelamotrigine extended-release | Lamotrigine 50 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4442 |