Lamotrigine
- Product NDC
- 10370-208
- 11-digit product format
- 103700208
- Labeler code
- 10370
- Product ID
- 10370-208_4e8e57a4-ecd3-4fce-943c-1ad74ea1ecc6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lamotrigine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA201374
- Marketing category
- ANDA
- Marketing start
- 2026-01-02
- 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
- Brand name suffix
- Extended-Release
- 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 | 850087, 900156, 1098608, 1146690 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10370-208-11 | LamotrigineExtended-Release | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 7 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 10370-208-11 | 10370020811 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-208-11) | 2026-01-02 | No | No | Current |