Felbamate
- Product NDC
- 0121-0891
- 11-digit product format
- 001210891
- Labeler code
- 0121
- Product ID
- 0121-0891_a4ea9cbb-b342-4c0b-e053-2995a90aa866
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Felbamate
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Pharmaceutical Associates, Inc.
- Application
- ANDA206314
- Marketing category
- ANDA
- Marketing start
- 2017-06-16
- Marketing end
- 0000-00-00
- Substance
- FELBAMATE
- Active strength
- 600 mg/5mL
- Pharmacologic classes
- Anti-epileptic Agent [EPC],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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0121-0891-20 | 00121089120 | 2 TRAY in 1 CASE (0121-0891-20) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0891-05) | 2 tray | 2020-05-21 | 0000-00-00 | No | No | Current |