Eslicarbazepine acetate
- Product NDC
- 31722-428
- 11-digit product format
- 317220428
- Labeler code
- 31722
- Product ID
- 31722-428_35c91221-dff8-9144-e063-6394a90a57fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eslicarbazepine acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA211186
- Marketing category
- ANDA
- Marketing start
- 2023-08-03
- 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 |
|---|
| 31722-428-30 | Eslicarbazepine acetate | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 31722-428-31 | Eslicarbazepine acetate | 10 in 1 BLISTER PACK | TABLET | 10 | | 2 |
| 31722-428-32 | Eslicarbazepine acetate | 10 in 1 CARTON | TABLET | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-428 | ESLICARBAZEPINE ACETATE (ESLICARBAZEPINE ACETATE) TABLET [CAMBER PHARMACEUTICALS, INC.] | 2 | Current NDC, 3 package rows | 20250524_6200ae2e-ac4e-41b6-a1c3-0ea00703d7e3.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 |
|---|
| 31722-428-30 | 31722042830 | 30 TABLET in 1 BOTTLE (31722-428-30) | 30 tablet | 2023-08-03 | No | No | Historical |
| 31722-428-31 | 31722042831 | 10 in 1 BLISTER PACK | | | | | Historical |
| 31722-428-32 | 31722042832 | 10 BLISTER PACK in 1 CARTON (31722-428-32) / 10 TABLET in 1 BLISTER PACK (31722-428-31) | 10 blister pack | 2023-08-03 | No | No | Historical |