Tiagabine Hydrochloride

Product NDC
72205-087
11-digit product format
722050087
Labeler code
72205
Product ID
72205-087_7c034fe0-cdac-49e1-8e39-592846ea3bec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tiagabine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA214816
Marketing category
ANDA
Marketing start
2021-11-23
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tiagabine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIAGABINE HYDROCHLORIDE16 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDQH6T6D8OY
Rxcui1299903, 1299909, 1299911, 1299917

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b72e14f-1cc2-c389-aef5-c9c0a7b93fb8Product name420220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-087-30Tiagabine Hydrochloride30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-087-30EA - Each72205-0874e0eda8a-318d-4a00-b4bc-41a15f15605912022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-087TIAGABINE HYDROCHLORIDE TABLET [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, Legacy NDC, 1 package rows20211124_7c034fe0-cdac-49e1-8e39-592846ea3bec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299903tiaGABine HCl 12 MG Oral TabletPSN7c034fe0-cdac-49e1-8e39-592846ea3bec1
1299909tiaGABine HCl 16 MG Oral TabletPSN7c034fe0-cdac-49e1-8e39-592846ea3bec1
1299911tiaGABine HCl 2 MG Oral TabletPSN7c034fe0-cdac-49e1-8e39-592846ea3bec1
1299917tiaGABine HCl 4 MG Oral TabletPSN7c034fe0-cdac-49e1-8e39-592846ea3bec1
1299903tiagabine hydrochloride 12 MG Oral TabletSCD7c034fe0-cdac-49e1-8e39-592846ea3bec1
1299909tiagabine hydrochloride 16 MG Oral TabletSCD7c034fe0-cdac-49e1-8e39-592846ea3bec1
1299911tiagabine hydrochloride 2 MG Oral TabletSCD7c034fe0-cdac-49e1-8e39-592846ea3bec1
1299917tiagabine hydrochloride 4 MG Oral TabletSCD7c034fe0-cdac-49e1-8e39-592846ea3bec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-087-307220500873030 TABLET in 1 BOTTLE (72205-087-30) 30 tablet2021-11-230000-00-00NoNoCurrent