LAMOTRIGINE
- Product NDC
- 76519-1165
- 11-digit product format
- 765191165
- Labeler code
- 76519
- Product ID
- 76519-1165_839e9c4c-bff9-fda2-e053-2a91aa0a9be4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LAMOTRIGINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- H. J. Harkins Company Inc.
- Application
- ANDA077783
- Marketing category
- ANDA
- Marketing start
- 2018-12-21
- Marketing end
- 0000-00-00
- Substance
- LAMOTRIGINE
- Active strength
- 200 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
- 2020-12-31
- 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 |
|---|
| 76519-1165-0 | LAMOTRIGINE | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 76519-1165-3 | LAMOTRIGINE | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76519-1165 | LAMOTRIGINE TABLET [H. J. HARKINS COMPANY INC.] | 2 | Legacy NDC, 2 package rows | 20190312_60f3672f-4ca3-17ea-e053-2991aa0a6b5e.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 |
|---|
| 76519-1165-0 | 76519116500 | 100 TABLET in 1 BOTTLE (76519-1165-0) | 100 tablet | 2018-12-21 | 0000-00-00 | No | No | Current |
| 76519-1165-3 | 76519116503 | 30 TABLET in 1 BOTTLE (76519-1165-3) | 30 tablet | 2018-12-21 | 0000-00-00 | No | No | Current |