lamotrigine
- Product NDC
- 69117-0049
- 11-digit product format
- 691170049
- Labeler code
- 69117
- Product ID
- 69117-0049_47239426-3d75-73d8-e063-6294a90a608d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lamotrigine extended-release
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Yiling Pharmaceutical, Inc.
- Application
- ANDA213949
- Marketing category
- ANDA
- Marketing start
- 2021-12-09
- Substance
- LAMOTRIGINE
- Active strength
- 300 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 | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 850087, 850091, 900156, 900164, 1098608, 1146690 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69117-0049-1 | lamotrigine | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 7 |
| 69117-0049-2 | lamotrigine | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 7 |
| 69117-0049-3 | lamotrigine | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69117-0049 | LAMOTRIGINE (LAMOTRIGINE EXTENDED-RELEASE) TABLET, FILM COATED, EXTENDED RELEASE [YILING PHARMACEUTICAL, INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20250101_f7de11a5-5357-4753-b1ac-b15123b50028.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 |
|---|
| 69117-0049-1 | 69117004901 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0049-1) | 2021-12-09 | 0000-00-00 | No | No | Current |
| 69117-0049-2 | 69117004902 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0049-2) | 2021-12-09 | 0000-00-00 | No | No | Current |
| 69117-0049-3 | 69117004903 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0049-3) | 2021-12-09 | 0000-00-00 | No | No | Current |