LAMOTRIGINE
- Product NDC
- 13668-048
- 11-digit product format
- 136680048
- Labeler code
- 13668
- Product ID
- 13668-048_e20d1c8d-dadf-4a54-8f0c-4ce62087f2e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LAMOTRIGINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA078947
- Marketing category
- ANDA
- Marketing start
- 2009-01-27
- Substance
- LAMOTRIGINE
- Active strength
- 150 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 | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 198427, 198428, 198429, 282401, 751139, 751563, 753451 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-048 | LAMOTRIGINE TABLET LAMOTRIGINE (LAMOTRIGINE) KIT [TORRENT PHARMACEUTICALS LIMITED] | 23 | Current NDC, Legacy NDC, 6 package rows | 20240830_3448839b-4933-4ef9-a80a-9e504d2c5696.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 753451 | {14 (lamotrigine 100 MG Oral Tablet) / 84 (lamotrigine 25 MG Oral Tablet) } Pack | GPCK | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
| 751139 | {35 (lamotrigine 25 MG Oral Tablet) } Pack | GPCK | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
| 751563 | {7 (lamotrigine 100 MG Oral Tablet) / 42 (lamotrigine 25 MG Oral Tablet) } Pack | GPCK | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
| 198427 | lamoTRIgine 100 MG Oral Tablet | PSN | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
| 198428 | lamoTRIgine 150 MG Oral Tablet | PSN | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
| 198429 | lamoTRIgine 200 MG Oral Tablet | PSN | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
| 751563 | lamoTRIgine 25 MG (42), 100 MG (7) Oral Tablet 49 Count Pack | PSN | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
| 753451 | lamoTRIgine 25 MG (84), 100 MG (14) Oral Tablet 98 Count Pack | PSN | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
| 282401 | lamoTRIgine 25 MG Oral Tablet | PSN | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
| 751139 | lamoTRIgine 25 MG Oral Tablet 35 Count Pack | PSN | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
| 198427 | lamotrigine 100 MG Oral Tablet | SCD | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
| 198428 | lamotrigine 150 MG Oral Tablet | SCD | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
| 198429 | lamotrigine 200 MG Oral Tablet | SCD | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
| 282401 | lamotrigine 25 MG Oral Tablet | SCD | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
| 751139 | lamotrigine Blue (For Patients Taking Valproate) | SY | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
| 753451 | lamotrigine Green (For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate) | SY | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
| 751563 | lamotrigine Orange (USP Starter Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate) | SY | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 26 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13668-048-01 | 13668004801 | 100 TABLET in 1 BOTTLE (13668-048-01) | 100 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |
| 13668-048-05 | 13668004805 | 500 TABLET in 1 BOTTLE (13668-048-05) | 500 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |
| 13668-048-16 | 13668004816 | 1600 TABLET in 1 BOTTLE (13668-048-16) | 1600 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |
| 13668-048-30 | 13668004830 | 30 TABLET in 1 BOTTLE (13668-048-30) | 30 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |
| 13668-048-60 | 13668004860 | 60 TABLET in 1 BOTTLE (13668-048-60) | 60 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |
| 13668-048-64 | 13668004864 | 90 TABLET in 1 DOSE PACK (13668-048-64) | 90 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |