Tiagabine Hydrochloride
- Product NDC
- 0093-8076
- 11-digit product format
- 000938076
- Labeler code
- 0093
- Product ID
- 0093-8076_2a8d7987-54ae-45d7-8224-361dac37e0a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tiagabine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- NDA020646
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-03-09
- Marketing end
- 2026-10-31
- Substance
- TIAGABINE HYDROCHLORIDE
- Active strength
- 16 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tiagabine Hydrochloride
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIAGABINE HYDROCHLORIDE | 16 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DQH6T6D8OY |
| Rxcui | 1299903, 1299909, 1299911, 1299917 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-8076-56 | Tiagabine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-8076 | TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 16 | Current NDC, Legacy NDC, 1 package rows | 20240828_953ef3cc-e3cb-480f-b9ea-256520fd62b8.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 |
|---|
| 0093-8076-56 | 00093807656 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-8076-56) | 2018-03-09 | 2026-10-31 | No | No | Current |