Levetiracetam
- Product NDC
- 16714-035
- 11-digit product format
- 167140035
- Labeler code
- 16714
- Product ID
- 16714-035_40911071-2280-bd37-e063-6394a90a0156
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA090515
- Marketing category
- ANDA
- Marketing start
- 2020-10-15
- 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
- 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 | 311288, 311289, 311290, 387003 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-035-01 | Levetiracetam | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 7 |
| 16714-035-02 | Levetiracetam | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-035 | LEVETIRACETAM (LEVETIRACETAM) TABLET, FILM COATED [NORTHSTAR RXLLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240511_3884cb76-822b-400d-9b24-49c286c9b6f7.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 |
|---|
| 16714-035-01 | 16714003501 | 120 TABLET, FILM COATED in 1 BOTTLE (16714-035-01) | 2020-10-15 | 0000-00-00 | No | No | Current |
| 16714-035-02 | 16714003502 | 500 TABLET, FILM COATED in 1 BOTTLE (16714-035-02) | 2020-10-15 | 0000-00-00 | No | No | Current |