lamotrigine
- Product NDC
- 70518-4638
- 11-digit product format
- 705184638
- Labeler code
- 70518
- Product ID
- 70518-4638_5074fdbb-6f4f-b13e-e063-6394a90a52be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lamotrigine extended-release
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA213949
- Marketing category
- ANDA
- Marketing start
- 2026-04-27
- Substance
- LAMOTRIGINE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- lamotrigine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LAMOTRIGINE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 900156 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4638-0 | lamotrigine | 50 in 1 BOX | TABLET, FILM COATED, EXTENDED RE | 50 | | 1 |
| 70518-4638-1 | lamotrigine | 1 in 1 POUCH | TABLET, FILM COATED, EXTENDED RE | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4638-0 | 70518463800 | 50 POUCH in 1 BOX (70518-4638-0) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-4638-1) | 50 pouch | 2026-04-27 | No | No | Historical |
| 70518-4638-1 | 70518463801 | 1 in 1 POUCH | | | | | Historical |