Lamotrigine
- Product NDC
- 70518-4121
- 11-digit product format
- 705184121
- Labeler code
- 70518
- Product ID
- 70518-4121_4d65e768-faa2-1d32-e063-6394a90a93dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA202383
- Marketing category
- ANDA
- Marketing start
- 2024-07-10
- Substance
- LAMOTRIGINE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 850091 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4121-0 | Lamotrigine | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4121 | LAMOTRIGINE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20240702_260dc37d-6e64-4688-82dc-10a1a428af17.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4121-0 | 70518412100 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4121-0) | 2024-07-10 | No | No | Historical |