Lamotrigine
- Product NDC
- 63629-8283
- 11-digit product format
- 636298283
- Labeler code
- 63629
- Product ID
- 63629-8283_8de025d9-0481-49cb-bc55-fbcd96436de0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202383
- Marketing category
- ANDA
- Marketing start
- 2013-06-20
- Marketing end
- 0000-00-00
- Substance
- LAMOTRIGINE
- Active strength
- 25 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
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8283 | LAMOTRIGINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 2 | Legacy NDC | 20220120_8de025d9-0481-49cb-bc55-fbcd96436de0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8283-1 | 63629828301 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8283-1) | 2013-06-20 | 0000-00-00 | No | No | Current |