Eslicarbazepine Acetate
- Product NDC
- 68180-290
- 11-digit product format
- 681800290
- Labeler code
- 68180
- Product ID
- 68180-290_2c3d221b-f0d3-4845-8bbc-9a4df2f0cc33
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eslicarbazepine Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA211246
- Marketing category
- ANDA
- Marketing start
- 2025-05-06
- Substance
- ESLICARBAZEPINE ACETATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eslicarbazepine Acetate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESLICARBAZEPINE ACETATE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BEA68ZVB2K |
| Rxcui | 1482507, 1482515, 1482521, 1482525 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-290-06 | Eslicarbazepine Acetate | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-290 | ESLICARBAZEPINE ACETATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 6 | Current NDC, 1 package rows | 20250508_999b341f-fe13-4dd9-bb95-9b0d6a817c4c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68180-290-06 | 68180029006 | 30 TABLET in 1 BOTTLE (68180-290-06) | 30 tablet | 2025-05-06 | No | No | Current |