Lamotrigine
- Product NDC
- 29300-113
- 11-digit product format
- 293000113
- Labeler code
- 29300
- Product ID
- 29300-113_03f59daf-b60e-46d1-b121-6a39361ee4f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA090170
- Marketing category
- ANDA
- Marketing start
- 2011-11-01
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lamotrigine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LAMOTRIGINE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 198427, 198428, 198429, 282401 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 29300-113-05 | Lamotrigine | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 24 |
| 29300-113-10 | Lamotrigine | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 24 |
| 29300-113-16 | Lamotrigine | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LAMOTRIGINE | ACTIVE INGREDIENT | U3H27498KS | LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 7 | |
| LAMOTRIGINE | ACTIVE MOIETY | U3H27498KS | LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 7 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 7 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 7 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-113 | LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 22 | Current NDC, Legacy NDC, 3 package rows | 20250529_4b72ea7a-a0b0-4980-84ad-84f64e2e6368.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 |
|---|
| 29300-113-05 | 29300011305 | 500 TABLET in 1 BOTTLE, PLASTIC (29300-113-05) | 500 tablet | 2011-11-01 | 0000-00-00 | No | No | Current |
| 29300-113-10 | 29300011310 | 1000 TABLET in 1 BOTTLE, PLASTIC (29300-113-10) | 1000 tablet | 2011-11-01 | 0000-00-00 | No | No | Current |
| 29300-113-16 | 29300011316 | 60 TABLET in 1 BOTTLE, PLASTIC (29300-113-16) | 60 tablet | 2011-11-01 | 0000-00-00 | No | No | Current |