Lamotrigine
- Product NDC
- 58118-1111
- 11-digit product format
- 581181111
- Labeler code
- 58118
- Product ID
- 58118-1111_abfa2d59-6855-23f7-e053-2a95a90afc1a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Clinical Solutions Wholesale, LLC
- Application
- ANDA090170
- Marketing category
- ANDA
- Marketing start
- 2019-10-08
- 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
- 2021-12-31
- 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 |
|---|
| 58118-1111 | LAMOTRIGINE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 2 | Legacy NDC | 20200804_dd9850b8-05a2-4d70-9a42-19f43b2d14a3.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58118-1111-8 | 58118111108 | 30 TABLET in 1 BLISTER PACK (58118-1111-8) | 30 tablet | 2019-10-08 | 0000-00-00 | No | No | Current |