Lamotrigine
- Product NDC
- 49884-486
- 11-digit product format
- 498840486
- Labeler code
- 49884
- Product ID
- 49884-486_983458ba-0e97-42af-952c-3662407dde00
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA204158
- Marketing category
- ANDA
- Marketing start
- 2015-12-16
- Substance
- LAMOTRIGINE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lamotrigine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LAMOTRIGINE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 103968, 198430, 252478, 252479, 851748, 851750, 851752 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49884-486-11 | Lamotrigine | 30 in 1 DOSE PACK | TABLET, ORALLY DISINTEGRATING | 30 | | 45 |
| 49884-486-41 | Lamotrigine | 14 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 14 | | 45 |
| 49884-486-77 | Lamotrigine | 16 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 16 | | 45 |
| 49884-486-93 | Lamotrigine | 7 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 7 | | 45 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-486 | LAMOTRIGINE TABLET, ORALLY DISINTEGRATING LAMOTRIGINE KIT [ENDO USA, INC.] | 40 | Current NDC, Legacy NDC, 4 package rows | 20241212_003663e5-c0c7-4fc1-a64d-313f2a5b10d2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49884-486-11 | 49884048611 | 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK (49884-486-11) | 2015-12-16 | 0000-00-00 | No | No | Current |
| 49884-486-41 | 49884048641 | 14 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-486-41) | 2015-12-16 | 0000-00-00 | No | No | Current |
| 49884-486-77 | 49884048677 | 16 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-486-77) | 2015-12-16 | 0000-00-00 | No | No | Current |
| 49884-486-93 | 49884048693 | 7 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-486-93) | 2015-12-16 | 0000-00-00 | No | No | Current |