Levetiracetam
- Product NDC
- 67877-768
- 11-digit product format
- 678770768
- Labeler code
- 67877
- Product ID
- 67877-768_40d1180e-73b5-4e73-8d42-15b99313496f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA216375
- Marketing category
- ANDA
- Marketing start
- 2022-05-28
- Substance
- LEVETIRACETAM
- Active strength
- 250 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
- Levetiracetam
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVETIRACETAM | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 44YRR34555 |
| Rxcui | 311288, 311289, 311290, 387003 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-768-05 | Levetiracetam | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 13 |
| 67877-768-12 | Levetiracetam | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 13 |
| 67877-768-30 | Levetiracetam | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 13 |
| 67877-768-33 | Levetiracetam | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 13 |
| 67877-768-33 | Levetiracetam | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-768 | LEVETIRACETAM TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 13 | Current NDC, Legacy NDC, 5 package rows | 20241115_591dd9f1-3681-4b2f-b096-7536826e3648.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 |
|---|
| 67877-768-05 | 67877076805 | 500 TABLET, FILM COATED in 1 BOTTLE (67877-768-05) | | 2022-05-28 | 0000-00-00 | No | No | Current |
| 67877-768-12 | 67877076812 | 120 TABLET, FILM COATED in 1 BOTTLE (67877-768-12) | | 2022-05-28 | 0000-00-00 | No | No | Current |
| 67877-768-30 | 67877076830 | 30 TABLET, FILM COATED in 1 BOTTLE (67877-768-30) | | 2022-05-28 | 0000-00-00 | No | No | Current |
| 67877-768-33 | 67877076833 | 1 BLISTER PACK in 1 CARTON (67877-768-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2022-05-28 | 0000-00-00 | No | No | Current |