Levetiracetam
- Product NDC
- 71205-728
- 11-digit product format
- 712050728
- Labeler code
- 71205
- Product ID
- 71205-728_a0ad8200-70c9-4f4f-86c5-4a8c6c9f0223
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA205130
- Marketing category
- ANDA
- Marketing start
- 2021-09-30
- Substance
- LEVETIRACETAM
- Active strength
- 500 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
- Brand name suffix
- ER
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVETIRACETAM | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 44YRR34555 |
| Rxcui | 807832 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-728-30 | LevetiracetamER | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 30 | | 1 |
| 71205-728-60 | LevetiracetamER | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 60 | | 1 |
| 71205-728-90 | LevetiracetamER | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-728 | LEVETIRACETAM ER (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 1 | Current NDC, Legacy NDC, 3 package rows | 20221211_a0ad8200-70c9-4f4f-86c5-4a8c6c9f0223.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71205-728-30 | 71205072830 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-728-30) | 2022-12-08 | 0000-00-00 | No | No | Current |
| 71205-728-60 | 71205072860 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-728-60) | 2022-12-08 | 0000-00-00 | No | No | Current |
| 71205-728-90 | 71205072890 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-728-90) | 2022-12-08 | 0000-00-00 | No | No | Current |