ELEPSIA XR 1500 MG
- Product NDC
- 80705-101
- 11-digit product format
- 807050101
- Labeler code
- 80705
- Product ID
- 80705-101_3c463bee-1191-4cab-b4d0-367673db19ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levetiracetam
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- TRIPOINT THERAPEUTICS, LLC
- Application
- NDA204417
- Marketing category
- NDA
- Marketing start
- 2021-02-12
- Substance
- LEVETIRACETAM
- Active strength
- 1500 mg/1
- Pharmacologic classes
- 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
- ELEPSIA XR 1500 MG
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVETIRACETAM | 1500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 44YRR34555 |
| Rxcui | 1605362, 1605368, 1605372, 1605374 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80705-101-02 | ELEPSIA XR 1500 MG | 2 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 2 | | 5 |
| 80705-101-02 | ELEPSIA XR 1500 MG | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 5 |
| 80705-101-30 | ELEPSIA XR 1500 MG | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 5 |
| 80705-101-99 | ELEPSIA XR 1500 MG | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 5 |
| 80705-101-99 | ELEPSIA XR 1500 MG | 7 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 7 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80705-101 | ELEPSIA XR 1000 MG (LEVETIRACETAM) TABLET, EXTENDED RELEASE ELEPSIA XR 1500 MG (LEVETIRACETAM) TABLET, EXTENDED RELEASE [TRIPOINT THERAPEUTICS, LLC] | 5 | Current NDC, Legacy NDC, 5 package rows | 20240328_cac83d47-88a2-4447-a0c0-90b44ffda0ac.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 |
|---|
| 80705-101-02 | 80705010102 | 1 BLISTER PACK in 1 CARTON (80705-101-02) / 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2021-09-29 | 0000-00-00 | No | No | Current |
| 80705-101-30 | 80705010130 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80705-101-30) | | 2021-02-12 | 0000-00-00 | No | No | Current |
| 80705-101-99 | 80705010199 | 1 BLISTER PACK in 1 CARTON (80705-101-99) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2021-02-12 | 0000-00-00 | No | No | Current |