Lamotrigine
- Product NDC
- 64725-0112
- 11-digit product format
- 647250112
- Labeler code
- 64725
- Product ID
- 64725-0112_858f7e7f-5d6b-46dc-a1df-4e3e7229ea24
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TYA Pharmaceuticals
- 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
- 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 |
|---|---|---|---|---|---|
| 64725-0112-1 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4d85-60a7-e053-dbdaa90a05bd | 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 |
|---|---|---|---|---|---|---|
| 64725-0112-1 | Lamotrigine | 100 in 1 BOTTLE | TABLET | 100 | 4 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LAMOTRIGINE | ACTIVE INGREDIENT | U3H27498KS | LAMOTRIGINE TABLET [TYA PHARMACEUTICALS] | 4 | |
| LAMOTRIGINE | ACTIVE MOIETY | U3H27498KS | LAMOTRIGINE TABLET [TYA PHARMACEUTICALS] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LAMOTRIGINE TABLET [TYA PHARMACEUTICALS] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LAMOTRIGINE TABLET [TYA PHARMACEUTICALS] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LAMOTRIGINE TABLET [TYA PHARMACEUTICALS] | 4 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | LAMOTRIGINE TABLET [TYA PHARMACEUTICALS] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LAMOTRIGINE TABLET [TYA PHARMACEUTICALS] | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64725-0112 | LAMOTRIGINE TABLET [TYA PHARMACEUTICALS] | 4 | Legacy NDC, 1 package rows | 20140928_05405214-6215-432a-aa53-f7e03f35c7b1.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198427 | lamoTRIgine 100 MG Oral Tablet | PSN | 05405214-6215-432a-aa53-f7e03f35c7b1 | 4 |
| 282401 | lamoTRIgine 25 MG Oral Tablet | PSN | 05405214-6215-432a-aa53-f7e03f35c7b1 | 4 |
| 198427 | lamotrigine 100 MG Oral Tablet | SCD | 05405214-6215-432a-aa53-f7e03f35c7b1 | 4 |
| 282401 | lamotrigine 25 MG Oral Tablet | SCD | 05405214-6215-432a-aa53-f7e03f35c7b1 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 64725-0112-1 | 64725011201 | 100 in 1 BOTTLE | Historical |