lamotrigine
- Product NDC
- 82804-022
- 11-digit product format
- 828040022
- Labeler code
- 82804
- Product ID
- 82804-022_39efe933-bfed-4a6a-b270-0883871c5186
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lamotrigine extended-release
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA213949
- Marketing category
- ANDA
- Marketing start
- 2021-12-09
- 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
- 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 | 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 |
|---|
| 82804-022-30 | lamotrigine | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 1 |
| 82804-022-60 | lamotrigine | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 1 |
| 82804-022-90 | lamotrigine | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-022 | LAMOTRIGINE (LAMOTRIGINE EXTENDED-RELEASE) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 1 | Current NDC, 3 package rows | 20231012_39efe933-bfed-4a6a-b270-0883871c5186.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-022-30 | 82804002230 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-022-30) | 2023-10-11 | No | No | Current |
| 82804-022-60 | 82804002260 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-022-60) | 2023-10-11 | No | No | Current |
| 82804-022-90 | 82804002290 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-022-90) | 2023-10-11 | No | No | Current |