Lamotrigine
- Product NDC
- 68462-229
- 11-digit product format
- 684620229
- Labeler code
- 68462
- Product ID
- 68462-229_fc701d94-bfc5-44c4-8667-6414ee7226ed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA079099
- Marketing category
- ANDA
- Marketing start
- 2009-02-19
- 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
- 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 311264, 311265 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-229-01 | Lamotrigine | 100 in 1 BOTTLE | TABLET, CHEWABLE | 100 | | 26 |
| 68462-229-10 | Lamotrigine | 1000 in 1 BOTTLE | TABLET, CHEWABLE | 1000 | | 26 |
| 68462-229-90 | Lamotrigine | 90 in 1 BOTTLE | TABLET, CHEWABLE | 90 | | 26 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LAMOTRIGINE | ACTIVE INGREDIENT | U3H27498KS | LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA] | 15 | |
| LAMOTRIGINE | ACTIVE MOIETY | U3H27498KS | LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA] | 15 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA] | 15 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA] | 15 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA] | 15 | |
| POVIDONE K25 | INACTIVE INGREDIENT | K0KQV10C35 | LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA] | 15 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA] | 15 | |
| SODIUM STARCH GLYCOLATE TYPE B POTATO | INACTIVE INGREDIENT | 27NA468985 | LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA] | 15 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-229 | LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA] | 24 | Current NDC, Legacy NDC, 3 package rows | 20240621_50fcf452-2d21-493e-a1dd-0c6ea9ac6184.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68462-229-01 | 68462022901 | 100 TABLET, CHEWABLE in 1 BOTTLE (68462-229-01) | 2009-02-19 | 0000-00-00 | No | No | Current |
| 68462-229-10 | 68462022910 | 1000 TABLET, CHEWABLE in 1 BOTTLE (68462-229-10) | 2009-02-19 | 0000-00-00 | No | No | Current |
| 68462-229-90 | 68462022990 | 90 TABLET, CHEWABLE in 1 BOTTLE (68462-229-90) | 2009-02-19 | 0000-00-00 | No | No | Current |