Lamotrigine
- Product NDC
- 16571-785
- 11-digit product format
- 165710785
- Labeler code
- 16571
- Product ID
- 16571-785_fb2baf85-46db-4796-ac31-159a318db234
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA090401
- Marketing category
- ANDA
- Marketing start
- 2009-11-04
- Substance
- LAMOTRIGINE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 311264, 311265 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-785-01 | Lamotrigine | 100 in 1 BOTTLE | TABLET, CHEWABLE | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-785 | LAMOTRIGINE TABLET, CHEWABLE [RISING PHARMA HOLDINGS, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231219_f54690b3-bcbb-4d94-95b9-b7591af00117.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 |
|---|
| 16571-785-01 | 16571078501 | 100 TABLET, CHEWABLE in 1 BOTTLE (16571-785-01) | 2009-11-04 | 0000-00-00 | No | No | Current |