Lamotrigine
- Product NDC
- 21695-228
- 11-digit product format
- 216950228
- Labeler code
- 21695
- Product ID
- 21695-228_7332e0ea-fbd0-43fb-8d1e-f7068504c61d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA078525
- Marketing category
- NDA
- Marketing start
- 2009-01-27
- Marketing end
- 0000-00-00
- Substance
- LAMOTRIGINE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 14a9502b-3d70-0496-a7e1-b16edaa005b8 | Product name | 5 | 20250423 |
| 16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0 | Product name | 7 | 20250401 |
| e29d8e8b-4bc8-ebaf-f18e-e35287b19d6a | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-228-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4791-48b1-e053-8cdaa90a720a | These highlights do not include all the information needed to use LAMOTRIGINE safely and effectively. See full prescribing information for LAMOTRIGINE. LAMOTRIGINE Tablets Initial U.S. Approval: 1994 |
| 21695-228-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4791-48b1-e053-8cdaa90a720a | These highlights do not include all the information needed to use LAMOTRIGINE safely and effectively. See full prescribing information for LAMOTRIGINE. LAMOTRIGINE Tablets Initial U.S. Approval: 1994 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-228-30 | Lamotrigine | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 21695-228-60 | Lamotrigine | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-228-30 | EA - Each | 21695-228 | 81529323-465d-46d4-a1fa-2362ff81da14 | 1 | 2012-07-24 |
| 21695-228-60 | EA - Each | 21695-228 | da5949d9-ce74-4403-b174-6b617220b242 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198427 | lamoTRIgine 100 MG Oral Tablet | PSN | 7332e0ea-fbd0-43fb-8d1e-f7068504c61d | 1 |
| 198428 | lamoTRIgine 150 MG Oral Tablet | PSN | 7332e0ea-fbd0-43fb-8d1e-f7068504c61d | 1 |
| 198429 | lamoTRIgine 200 MG Oral Tablet | PSN | 7332e0ea-fbd0-43fb-8d1e-f7068504c61d | 1 |
| 282401 | lamoTRIgine 25 MG Oral Tablet | PSN | 7332e0ea-fbd0-43fb-8d1e-f7068504c61d | 1 |
| 198427 | lamotrigine 100 MG Oral Tablet | SCD | 7332e0ea-fbd0-43fb-8d1e-f7068504c61d | 1 |
| 198428 | lamotrigine 150 MG Oral Tablet | SCD | 7332e0ea-fbd0-43fb-8d1e-f7068504c61d | 1 |
| 198429 | lamotrigine 200 MG Oral Tablet | SCD | 7332e0ea-fbd0-43fb-8d1e-f7068504c61d | 1 |
| 282401 | lamotrigine 25 MG Oral Tablet | SCD | 7332e0ea-fbd0-43fb-8d1e-f7068504c61d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-228-30 | 21695022830 | 30 in 1 BOTTLE | Historical |
| 21695-228-60 | 21695022860 | 60 in 1 BOTTLE | Historical |