Tiagabine Hydrochloride

Product NDC
69238-1105
11-digit product format
692381105
Labeler code
69238
Product ID
69238-1105_012eca85-d949-4fd3-863e-1fac922150b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tiagabine
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA208181
Marketing category
ANDA
Marketing start
2017-12-08
Marketing end
0000-00-00
Substance
TIAGABINE HYDROCHLORIDE
Active strength
4 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1105-3EA - Each69238-110526252fbf-f27a-4bac-a8d1-56604a57295d12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1105TIAGABINE HYDROCHLORIDE (TIAGABINE) TABLET [AMNEAL PHARMACEUTICALS NY LLC]7Legacy NDC20240102_7036c6df-6527-4701-b484-6b962914b52a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1105-36923811050330 TABLET in 1 BOTTLE (69238-1105-3) 30 tablet2017-12-080000-00-00NoNoCurrent