Lamotrigine
- Product NDC
- 33261-648
- 11-digit product format
- 332610648
- Labeler code
- 33261
- Product ID
- 33261-648_3ccfd582-29b5-4ea0-8f3b-2bd4fca4ace0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA090170
- Marketing category
- ANDA
- Marketing start
- 2011-11-01
- 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
- 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 |
|---|---|---|---|---|---|
| 33261-648-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4993-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use lamotrigine tablets USP safely and effectively. See full prescribing information for lamotrigine tablets USP. Lamotrigine Tablets USP Initial U.S. Approval: 1994 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33261-648-90 | Lamotrigine | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33261-648-90 | EA - Each | 33261-648 | bcb13891-1540-41b2-b0a4-016991f298b3 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LAMOTRIGINE | ACTIVE INGREDIENT | U3H27498KS | LAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| LAMOTRIGINE | ACTIVE MOIETY | U3H27498KS | LAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | LAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198427 | lamoTRIgine 100 MG Oral Tablet | PSN | 6d3f37b6-ad2e-470e-be6a-3de98479a941 | 1 |
| 198427 | lamotrigine 100 MG Oral Tablet | SCD | 6d3f37b6-ad2e-470e-be6a-3de98479a941 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 33261-648-90 | 33261064890 | 90 in 1 BOTTLE, PLASTIC | Historical |