LAMOTRIGINE
- Product NDC
- 69102-137
- 11-digit product format
- 691020137
- Labeler code
- 69102
- Product ID
- 69102-137_14718eaf-e725-48ef-b2f8-1bd20b3a7cba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LAMOTRIGINE
- Dosage form
- KIT
- Labeler
- OWP Pharmaceuticals, Inc.
- Application
- ANDA078947
- Marketing category
- ANDA
- Marketing start
- 2017-08-30
- 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
- Kit
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 198427, 282401, 751139, 751563, 753451 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69102-137-10 | LAMOTRIGINEKit | 1 in 1 BLISTER PACK | KIT | 1 | | 14 |
| 69102-137-10 | LAMOTRIGINEKit | 7 in 1 PACKAGE, COMBINATION | KIT | 7 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69102-137 | LAMOTRIGINE KIT (LAMOTRIGINE) KIT LAMOTRIGINE TABLET [OWP PHARMACEUTICALS, INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20250102_474fb321-575c-4b97-9dbe-080061652ee4.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 | 474fb321-575c-4b97-9dbe-080061652ee4 | 14 |
| 751139 | {35 (lamotrigine 25 MG Oral Tablet) } Pack | GPCK | 474fb321-575c-4b97-9dbe-080061652ee4 | 14 |
| 751563 | {7 (lamotrigine 100 MG Oral Tablet) / 42 (lamotrigine 25 MG Oral Tablet) } Pack | GPCK | 474fb321-575c-4b97-9dbe-080061652ee4 | 14 |
| 198427 | lamoTRIgine 100 MG Oral Tablet | PSN | 474fb321-575c-4b97-9dbe-080061652ee4 | 14 |
| 751563 | lamoTRIgine 25 MG (42), 100 MG (7) Oral Tablet 49 Count Pack | PSN | 474fb321-575c-4b97-9dbe-080061652ee4 | 14 |
| 753451 | lamoTRIgine 25 MG (84), 100 MG (14) Oral Tablet 98 Count Pack | PSN | 474fb321-575c-4b97-9dbe-080061652ee4 | 14 |
| 282401 | lamoTRIgine 25 MG Oral Tablet | PSN | 474fb321-575c-4b97-9dbe-080061652ee4 | 14 |
| 751139 | lamoTRIgine 25 MG Oral Tablet 35 Count Pack | PSN | 474fb321-575c-4b97-9dbe-080061652ee4 | 14 |
| 198427 | lamotrigine 100 MG Oral Tablet | SCD | 474fb321-575c-4b97-9dbe-080061652ee4 | 14 |
| 282401 | lamotrigine 25 MG Oral Tablet | SCD | 474fb321-575c-4b97-9dbe-080061652ee4 | 14 |
| 751139 | lamotrigine Blue (For Patients Taking Valproate) | SY | 474fb321-575c-4b97-9dbe-080061652ee4 | 14 |
| 753451 | lamotrigine Green (For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate) | SY | 474fb321-575c-4b97-9dbe-080061652ee4 | 14 |
| 751563 | lamotrigine Orange (USP Starter Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate) | SY | 474fb321-575c-4b97-9dbe-080061652ee4 | 14 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69102-137-10 | 69102013710 | 7 BLISTER PACK in 1 PACKAGE, COMBINATION (69102-137-10) / 1 KIT in 1 BLISTER PACK | 7 blister pack | 2017-08-30 | 0000-00-00 | No | No | Current |