Lamotrigine
- Product NDC
- 50090-2130
- 11-digit product format
- 500902130
- Labeler code
- 50090
- Product ID
- 50090-2130_a2a8622a-6df4-4c7e-b026-fd5080a9196a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA090170
- Marketing category
- ANDA
- Marketing start
- 2011-11-01
- Substance
- LAMOTRIGINE
- Active strength
- 100 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
openFDA Listing Details
- Product ID
- 50090-2130_a2a8622a-6df4-4c7e-b026-fd5080a9196a
- SPL ID
- a2a8622a-6df4-4c7e-b026-fd5080a9196a
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Lamotrigine
- Generic name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2011-11-01
- Marketing category
- ANDA
- Application number
- ANDA090170
- 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]
- Listing expiration
- 2027-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| LAMOTRIGINE | 100 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 198427, 198428, 282401 |
| Spl Set Id | 6139a858-700c-4eb9-9f84-99d280bde326 |
| Manufacturer Name | A-S Medication Solutions |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 50090-2130-0 | 30 TABLET in 1 BOTTLE (50090-2130-0) | 2015-10-15 | No |
| 50090-2130-1 | 60 TABLET in 1 BOTTLE (50090-2130-1) | 2015-10-15 | No |
| 50090-2130-2 | 90 TABLET in 1 BOTTLE (50090-2130-2) | 2018-03-15 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| U3H27498KS | LAMOTRIGINE | 84057-84-1 | LAMOTRIGINE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-2130-0 | 50090213000 | 30 TABLET in 1 BOTTLE (50090-2130-0) | 30 tablet | 2015-10-15 | No | No | Historical |
| 50090-2130-1 | 50090213001 | 60 TABLET in 1 BOTTLE (50090-2130-1) | 60 tablet | 2015-10-15 | No | No | Historical |
| 50090-2130-2 | 50090213002 | 90 TABLET in 1 BOTTLE (50090-2130-2) | 90 tablet | 2018-03-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lamotrigine | A-S Medication Solutions | 2026-03-02 | HUMAN PRESCRIPTION DRUG LABEL | 28 |