Lamotrigine
- Product NDC
- 64980-401
- 11-digit product format
- 649800401
- Labeler code
- 64980
- Product ID
- 64980-401_584d8b7a-c27f-448a-a98a-0f7dc8c9d944
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Rising Pharmaceuticals, Inc.
- Application
- ANDA090401
- Marketing category
- ANDA
- Marketing start
- 2009-11-04
- Marketing end
- 0000-00-00
- Substance
- LAMOTRIGINE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64980-401-01 | 64980040101 | 100 TABLET, CHEWABLE in 1 BOTTLE (64980-401-01) | 2009-11-04 | 0000-00-00 | No | No | Current |