Lamotrigine
- Product NDC
- 51672-4132
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA078525
- Marketing category
- ANDA
- Substance
- LAMOTRIGINE
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 51672-4132-0 | 10 BLISTER PACK in 1 CARTON (51672-4132-0) / 10 TABLET in 1 BLISTER PACK | 20090127 | | No | Historical |
| 51672-4132-1 | 100 TABLET in 1 BOTTLE (51672-4132-1) | 20090127 | | No | Historical |
| 51672-4132-2 | 500 TABLET in 1 BOTTLE (51672-4132-2) | 20221025 | | No | Historical |
| 51672-4132-3 | 1000 TABLET in 1 BOTTLE (51672-4132-3) | 20090127 | | No | Historical |
| 51672-4132-4 | 60 TABLET in 1 BOTTLE (51672-4132-4) | 20090127 | | No | Historical |
| 51672-4132-6 | 30 TABLET in 1 BOTTLE (51672-4132-6) | 20090127 | | No | Historical |
Related DailyMed Labels
| Set ID | Title | Manufacturer | Effective date | Type | Version |
|---|
| b829f9b2-f0ac-408a-a6f4-18b72150227d | These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994 | Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd. | 2025-11-26 | HUMAN PRESCRIPTION DRUG LABEL | 21 |
| 68a4dac2-5015-40c5-88ca-204098c3b288 | These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994 | Bryant Ranch Prepack | 2024-04-03 | HUMAN PRESCRIPTION DRUG LABEL | 102 |
| b829f9b2-f0ac-408a-a6f4-18b72150227d | These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994 | Taro Pharmaceuticals U.S.A., Inc. | Taro Pharmaceutical Industries Ltd. | 2023-05-09 | HUMAN PRESCRIPTION DRUG LABEL | 15 |
| 7332e0ea-fbd0-43fb-8d1e-f7068504c61d | These highlights do not include all the information needed to use LAMOTRIGINE safely and effectively. See full prescribing information for LAMOTRIGINE. LAMOTRIGINE Tablets Initial U.S. Approval: 1994 | Rebel Distributors Corp | 2010-09-30 | HUMAN PRESCRIPTION DRUG LABEL | 1 |