LAMOTRIGINE
- Product NDC
- 68788-7178
- 11-digit product format
- 687887178
- Labeler code
- 68788
- Product ID
- 68788-7178_3543d0fb-880f-4b32-a262-925ece93b235
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA077783
- Marketing category
- ANDA
- Marketing start
- 2018-07-13
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68788-7178-3 | 2021-02-01 | C162847 | 48780-1 | ba0f9c33-5be6-a910-e053-dadaa90a0b85 | 6c89e5a3-d267-4c7b-bcbf-8fe6c4470e52 |
| 68788-7178-6 | 2021-02-01 | C162847 | 48780-1 | ba0f9c33-5be6-a910-e053-dadaa90a0b85 | 6c89e5a3-d267-4c7b-bcbf-8fe6c4470e52 |
| 68788-7178-9 | 2021-02-01 | C162847 | 48780-1 | ba0f9c33-5be6-a910-e053-dadaa90a0b85 | 6c89e5a3-d267-4c7b-bcbf-8fe6c4470e52 |
| 68788-7178-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5be6-a910-e053-dadaa90a0b85 | 6c89e5a3-d267-4c7b-bcbf-8fe6c4470e52 |
| 68788-7178-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5be6-a910-e053-dadaa90a0b85 | 6c89e5a3-d267-4c7b-bcbf-8fe6c4470e52 |
| 68788-7178-9 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5be6-a910-e053-dadaa90a0b85 | 6c89e5a3-d267-4c7b-bcbf-8fe6c4470e52 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7178-3 | EA - Each | 68788-7178 | ae03a3f8-9e73-4d97-a982-4e5c4d154393 | 1 | 2018-09-05 |
| 68788-7178-6 | EA - Each | 68788-7178 | dcd9affb-9065-4fb0-ab94-30bae907757a | 1 | 2018-09-05 |
| 68788-7178-9 | EA - Each | 68788-7178 | a83eb7c3-5171-42c0-8d7b-c80bfe604bb5 | 1 | 2018-09-05 |