Lamotrigine
- Product NDC
- 67877-164
- 11-digit product format
- 678770164
- Labeler code
- 67877
- Product ID
- 67877-164_976bb1e6-e2b0-4900-9ca9-83eac46ed984
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA200694
- Marketing category
- ANDA
- Marketing start
- 2011-06-22
- Substance
- LAMOTRIGINE
- Active strength
- 25 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lamotrigine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LAMOTRIGINE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 198427, 198428, 198429, 282401 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-164-01 | Lamotrigine | 100 in 1 BOTTLE | TABLET | 100 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LAMOTRIGINE | ACTIVE INGREDIENT | U3H27498KS | LAMOTRIGINE TABLET [ASCEND LABORATORIES, LLC] | 11 | |
| LAMOTRIGINE | ACTIVE MOIETY | U3H27498KS | LAMOTRIGINE TABLET [ASCEND LABORATORIES, LLC] | 11 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LAMOTRIGINE TABLET [ASCEND LABORATORIES, LLC] | 11 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | LAMOTRIGINE TABLET [ASCEND LABORATORIES, LLC] | 11 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LAMOTRIGINE TABLET [ASCEND LABORATORIES, LLC] | 11 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LAMOTRIGINE TABLET [ASCEND LABORATORIES, LLC] | 11 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LAMOTRIGINE TABLET [ASCEND LABORATORIES, LLC] | 11 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | LAMOTRIGINE TABLET [ASCEND LABORATORIES, LLC] | 11 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LAMOTRIGINE TABLET [ASCEND LABORATORIES, LLC] | 11 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LAMOTRIGINE TABLET [ASCEND LABORATORIES, LLC] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-164 | LAMOTRIGINE TABLET [ASCEND LABORATORIES, LLC] | 17 | Current NDC, Legacy NDC, 1 package rows | 20221211_70cd448a-2921-4c69-bdf2-5a6ce883bd07.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67877-164-01 | 67877016401 | 100 TABLET in 1 BOTTLE (67877-164-01) | 100 tablet | 2011-06-22 | 0000-00-00 | No | No | Current |