Lamotrigine
- Product NDC
- 70518-1978
- 11-digit product format
- 705181978
- Labeler code
- 70518
- Product ID
- 70518-1978_498b82e4-2410-95ef-e063-6394a90a0322
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090170
- Marketing category
- ANDA
- Marketing start
- 2019-03-25
- Substance
- LAMOTRIGINE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lamotrigine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LAMOTRIGINE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 198428 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 70518-1978-0 | 2023-03-07 | C162847 | 48780-1 | f386c649-d27f-0266-e053-dadaa90a7c1a | 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 |
| 70518-1978-0 | 2023-03-07 | C162847 | 48780-1 | f386c649-d27f-0266-e053-dadaa90a7c1a | 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 |
| 70518-1978-0 | 2023-03-07 | C162847 | 48780-1 | f386c649-d27f-0266-e053-dadaa90a7c1a | 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 |
| 70518-1978-0 | 2023-03-07 | C162847 | 48780-1 | f386c649-d27f-0266-e053-dadaa90a7c1a | 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 |
| 70518-1978-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-d27f-0266-e053-dadaa90a7c1a | 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 |
| 70518-1978-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-d27f-0266-e053-dadaa90a7c1a | 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 |
| 70518-1978-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-d27f-0266-e053-dadaa90a7c1a | 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 |
| 70518-1978-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-d27f-0266-e053-dadaa90a7c1a | 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 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-1978-0 | Lamotrigine | 30 in 1 BLISTER PACK | TABLET | 30 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-1978 | LAMOTRIGINE TABLET [REMEDYREPACK INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20250510_811188be-d231-4b58-8d7a-b01b236fab51.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 |
|---|
| 70518-1978-0 | 70518197800 | 30 TABLET in 1 BLISTER PACK (70518-1978-0) | 30 tablet | 2019-03-25 | 0000-00-00 | No | No | Current |