SUBVENITE
- Product NDC
- 69102-418
- 11-digit product format
- 691020418
- Labeler code
- 69102
- Product ID
- 69102-418_2fc41672-1233-420d-be83-17165b23eea8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LAMOTRIGINE
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- OWP Pharmaceuticals, Inc.
- Application
- NDA218879
- Marketing category
- NDA
- Marketing start
- 2025-10-01
- Substance
- LAMOTRIGINE
- Active strength
- 10 mg/mL
- 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
- SUBVENITE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LAMOTRIGINE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 2724462, 2724466 |
DailyMed Product Concepts#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69102-418-01 | 69102041801 | 1 BOTTLE in 1 PACKAGE (69102-418-01) / 240 mL in 1 BOTTLE | 1 bottle | 2025-10-01 | No | No | Current |
| 69102-418-02 | 69102041802 | 2 BOTTLE in 1 PACKAGE (69102-418-02) / 240 mL in 1 BOTTLE | 2 bottle | 2025-10-01 | No | No | Current |