Lamotrigine
- Product NDC
- 53808-1003
- 11-digit product format
- 538081003
- Labeler code
- 53808
- Product ID
- 53808-1003_a59f10e6-5ec5-4351-9e2f-7b2d7d8bce25
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA078525
- Marketing category
- ANDA
- Marketing start
- 2014-11-01
- Marketing end
- 0000-00-00
- Substance
- LAMOTRIGINE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|---|---|---|---|---|
| 53808-1003-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-093f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LAMOTRIGINE safely and effectively. See full prescribing information for LAMOTRIGINE. LAMOTRIGINE Tablets, USP Initial U.S. Approval: 1994 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-1003-1 | Lamotrigine | 30 in 1 BLISTER PACK | TABLET | 30 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LAMOTRIGINE | ACTIVE INGREDIENT | U3H27498KS | LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| LAMOTRIGINE | ACTIVE MOIETY | U3H27498KS | LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-1003 | LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20150107_2ea96dec-633c-4afb-9cd1-30861712be9f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 282401 | lamoTRIgine 25 MG Oral Tablet | PSN | 2ea96dec-633c-4afb-9cd1-30861712be9f | 1 |
| 282401 | lamotrigine 25 MG Oral Tablet | SCD | 2ea96dec-633c-4afb-9cd1-30861712be9f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-1003-1 | 53808100301 | 30 in 1 BLISTER PACK | Historical |