Lamotrigine Extended Release
- Product NDC
- 49884-561
- 11-digit product format
- 498840561
- Labeler code
- 49884
- Product ID
- 49884-561_9c5e0c2a-800e-47e9-a26b-582b98a05957
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lamotrigine extended release
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA201791
- Marketing category
- ANDA
- Marketing start
- 2013-01-18
- Marketing end
- 2026-09-30
- Substance
- LAMOTRIGINE
- Active strength
- 25 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lamotrigine Extended Release
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LAMOTRIGINE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 850087, 850091, 900156, 900164, 1098608, 1146690 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49884-561-01 | Lamotrigine Extended Release | 100 in 1 BOTTLE | TABLET | 100 | | 21 |
| 49884-561-05 | Lamotrigine Extended Release | 500 in 1 BOTTLE | TABLET | 500 | | 21 |
| 49884-561-11 | Lamotrigine Extended Release | 30 in 1 BOTTLE | TABLET | 30 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-561 | LAMOTRIGINE EXTENDED RELEASE TABLET [ENDO USA, INC.] | 15 | Current NDC, Legacy NDC, 3 package rows | 20240913_fb59c76a-9b6f-40ea-ac3a-58c3195c4377.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49884-561-01 | 49884056101 | 100 TABLET in 1 BOTTLE (49884-561-01) | 100 tablet | 2013-01-18 | 0000-00-00 | No | No | Current |
| 49884-561-05 | 49884056105 | 500 TABLET in 1 BOTTLE (49884-561-05) | 500 tablet | 2013-01-18 | 0000-00-00 | No | No | Current |
| 49884-561-11 | 49884056111 | 30 TABLET in 1 BOTTLE (49884-561-11) | 30 tablet | 2013-01-18 | 2026-09-30 | No | No | Current |