LAMOTRIGINE
- Product NDC
- 61919-534
- 11-digit product format
- 619190534
- Labeler code
- 61919
- Product ID
- 61919-534_e4a334ed-cf5d-6f8b-e053-2995a90ace3d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LAMOTRIGINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DirectRX
- Application
- ANDA090170
- Marketing category
- ANDA
- Marketing start
- 2019-04-17
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 61919-534-30 | LAMOTRIGINE | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 61919-534-60 | LAMOTRIGINE | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-534 | LAMOTRIGINE TABLET [DIRECTRX] | 3 | Legacy NDC, 2 package rows | 20230509_86bf413c-f650-f995-e053-2991aa0ab3ce.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 |
|---|
| 61919-534-30 | 61919053430 | 30 TABLET in 1 BOTTLE (61919-534-30) | 30 tablet | 2019-04-17 | 0000-00-00 | No | No | Current |
| 61919-534-60 | 61919053460 | 60 TABLET in 1 BOTTLE (61919-534-60) | 60 tablet | 2022-07-25 | 0000-00-00 | No | No | Current |