LEVETIRACETAM EXTENDED RELEASE
- Product NDC
- 75834-245
- 11-digit product format
- 758340245
- Labeler code
- 75834
- Product ID
- 75834-245_69069c2b-6ee3-4003-b547-24d9a7a1b74c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVETIRACETAM
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Nivagen Pharmaceuticals, Inc.
- Application
- ANDA201464
- Marketing category
- ANDA
- Marketing start
- 2020-09-16
- Marketing end
- 0000-00-00
- Substance
- LEVETIRACETAM
- Active strength
- 500 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 75834-245-05 | 75834024505 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (75834-245-05) | 2020-09-16 | 0000-00-00 | No | No | Current |
| 75834-245-60 | 75834024560 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (75834-245-60) | 2020-09-16 | 0000-00-00 | No | No | Current |