Lamotrigine
- Product NDC
- 70518-2563
- 11-digit product format
- 705182563
- Labeler code
- 70518
- Product ID
- 70518-2563_4a67dac3-1748-45bd-e063-6294a90ad9d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077633
- Marketing category
- ANDA
- Marketing start
- 2020-02-04
- 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 | 198427 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-2563-0 | Lamotrigine | 30 in 1 BLISTER PACK | TABLET | 30 | | 14 |
| 70518-2563-1 | Lamotrigine | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2563 | LAMOTRIGINE TABLET [REMEDYREPACK INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250423_15d801a0-f0a5-40c1-bc88-d5ba9a02c696.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 |
|---|
| 70518-2563-0 | 70518256300 | 30 TABLET in 1 BLISTER PACK (70518-2563-0) | 30 tablet | 2020-02-04 | 0000-00-00 | No | No | Current |
| 70518-2563-1 | 70518256301 | 30 TABLET in 1 BOTTLE, PLASTIC (70518-2563-1) | 30 tablet | 2022-11-10 | 0000-00-00 | No | No | Current |