GABITRIL

Product NDC
68151-4235
11-digit product format
681514235
Labeler code
68151
Product ID
68151-4235_7c25748c-ffc7-452a-999a-414101b232d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tiagabine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA020646
Marketing category
NDA
Marketing start
2001-04-01
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b72e14f-1cc2-c389-aef5-c9c0a7b93fb8Product name420220613
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-4235-32020-01-31C16284748780-19d75b9d0-fcfd-f424-e053-dadaa90a57ceGABITRIL ® (tiagabine hydrochloride) Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4235-3GABITRIL1 in 1 PACKAGETABLET, FILM COATED13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIAGABINE HYDROCHLORIDEACTIVE INGREDIENTDQH6T6D8OYGABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]2
tiagabineACTIVE MOIETYZ80I64HMNPGABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RGABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GGABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4235GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160808_72b7f357-8827-4a8b-b55a-01fbce47ae80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299978Gabitril 4 MG Oral TabletPSN72b7f357-8827-4a8b-b55a-01fbce47ae803
1299917tiaGABine HCl 4 MG Oral TabletPSN72b7f357-8827-4a8b-b55a-01fbce47ae803
1299978tiagabine hydrochloride 4 MG Oral Tablet [Gabitril]SBD72b7f357-8827-4a8b-b55a-01fbce47ae803
1299917tiagabine hydrochloride 4 MG Oral TabletSCD72b7f357-8827-4a8b-b55a-01fbce47ae803
1299978Gabitril 4 MG Oral TabletSY72b7f357-8827-4a8b-b55a-01fbce47ae803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4235-3681514235031 in 1 PACKAGEHistorical