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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 76e81f18-c6b9-f226-530a-a6296d5cd5f4 | Product name | 6 | 20251106 |
| 087c9486-f4a9-a565-c6fb-d6fa49f4572a | Product name | 6 | 20230317 |
| 525a8d4d-1988-fc3f-e292-27fd384de4f0 | Product name | 8 | 20230104 |
| 32b651f8-caa7-6882-11c7-54c4ad21796b | Product name | 8 | 20201216 |
| ce453ca5-90cf-41ed-9de4-de519f70a0f2 | Product name | 2 | 20160303 |
| 66666eb8-1fa6-4a60-bae9-e564e73b4cd5 | Product name | 1 | 20150728 |
| eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477 | Product name | 1 | 20150410 |
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80705-101-30 | EA - Each | 80705-101 | ef4d995c-8def-429f-a237-d57e1a44821d | 1 | 2021-04-08 |
DailyMed Dashboard NDC Coverage#
| 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#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1605368 | Elepsia XR 1000 MG 24HR Extended Release Oral Tablet | PSN | cac83d47-88a2-4447-a0c0-90b44ffda0ac | 5 |
| 1605374 | Elepsia XR 1500 MG 24HR Extended Release Oral Tablet | PSN | cac83d47-88a2-4447-a0c0-90b44ffda0ac | 5 |
| 1605362 | levETIRAcetam 1000 MG 24HR Extended Release Oral Tablet | PSN | cac83d47-88a2-4447-a0c0-90b44ffda0ac | 5 |
| 1605372 | levETIRAcetam 1500 MG 24HR Extended Release Oral Tablet | PSN | cac83d47-88a2-4447-a0c0-90b44ffda0ac | 5 |
| 1605368 | 24 HR levetiracetam 1000 MG Extended Release Oral Tablet [Elepsia] | SBD | cac83d47-88a2-4447-a0c0-90b44ffda0ac | 5 |
| 1605374 | 24 HR levetiracetam 1500 MG Extended Release Oral Tablet [Elepsia] | SBD | cac83d47-88a2-4447-a0c0-90b44ffda0ac | 5 |
| 1605362 | 24 HR levetiracetam 1000 MG Extended Release Oral Tablet | SCD | cac83d47-88a2-4447-a0c0-90b44ffda0ac | 5 |
| 1605372 | 24 HR levetiracetam 1500 MG Extended Release Oral Tablet | SCD | cac83d47-88a2-4447-a0c0-90b44ffda0ac | 5 |
| 1605368 | 24 HR Elepsia 1000 MG Extended Release Oral Tablet | SY | cac83d47-88a2-4447-a0c0-90b44ffda0ac | 5 |
| 1605374 | 24 HR Elepsia 1500 MG Extended Release Oral Tablet | SY | cac83d47-88a2-4447-a0c0-90b44ffda0ac | 5 |
| 1605368 | Elepsia XR 1000 MG 24 HR Extended Release Oral Tablet | SY | cac83d47-88a2-4447-a0c0-90b44ffda0ac | 5 |
| 1605374 | Elepsia XR 1500 MG 24 HR Extended Release Oral Tablet | SY | cac83d47-88a2-4447-a0c0-90b44ffda0ac | 5 |
| 1605362 | levetiracetam 1000 MG 24 HR Extended Release Oral Tablet | SY | cac83d47-88a2-4447-a0c0-90b44ffda0ac | 5 |
| 1605372 | levetiracetam 1500 MG 24 HR Extended Release Oral Tablet | SY | cac83d47-88a2-4447-a0c0-90b44ffda0ac | 5 |
Packages#
| 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 |