GABITRIL
- Product NDC
- 63459-402
- 11-digit product format
- 634590402
- Labeler code
- 63459
- Product ID
- 63459-402_cdd94737-c30c-4035-8809-78c0ba68b88d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tiagabine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cephalon, LLC
- Application
- NDA020646
- Marketing category
- NDA
- Marketing start
- 2001-04-01
- Marketing end
- 0000-00-00
- Substance
- TIAGABINE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIAGABINE HYDROCHLORIDE | 2 mg/1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63459-402-30 | 63459040230 | 30 TABLET, FILM COATED in 1 BOTTLE (63459-402-30) | 2010-02-08 | 0000-00-00 | No | No | Current |
| 63459-402-99 | 63459040299 | 237000 TABLET, FILM COATED in 1 DRUM (63459-402-99) | 08-FEB-10 | | | | Current |