Lamotrigine
- Product NDC
- 46708-418
- 11-digit product format
- 467080418
- Labeler code
- 46708
- Product ID
- 46708-418_faee013c-cad2-4abb-904c-e6ff79ba778c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA211821
- Marketing category
- ANDA
- Marketing start
- 2024-10-07
- Substance
- LAMOTRIGINE
- Active strength
- 250 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lamotrigine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LAMOTRIGINE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 900156, 1098608, 1146690 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-418-30 | Lamotrigine | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 1 |
| 46708-418-91 | Lamotrigine | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-418 | LAMOTRIGINE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 2 package rows | 20241013_faee013c-cad2-4abb-904c-e6ff79ba778c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-418-30 | 46708041830 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-418-30) | 2024-10-07 | No | No | Current |
| 46708-418-91 | 46708041891 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-418-91) | 2024-10-07 | No | No | Current |